202 Ectd Jobs - Page 8

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting applications like docuBridge Suite from Lorenz and Disclose from Citeline, developing scalable solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime. The ideal candidate will have a strong background in regulatory submissions and clinical trials, along with innovative and transformational experience. Roles & Responsibilities: Take ownership of complex software projects from conception to deployment Manage software delivery scope, risk, and timeline Possesses strong rapid prototyping skills and can quickly translate concepts into working code Provide technical guidance and mentorship to junior developers Contribute to both front-end and back-end development using cloud technology Develop an innovative solution using generative AI technologies Conduct code reviews to ensure code quality and alignment to standard methodologies Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Stay updated with the latest trends and advancements Work closely with the product team, business team, and other partners Design, develop, implement, and maintain applications, including configurations, custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems, and translate them into software architecture and design specifications Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software Work on integrating applications with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently Design and implement systems and processes to improve the reliability, scalability, and performance of applications Develop and maintain monitoring tools and dashboards to track system health, performance, and availability Respond to and resolve incidents promptly, conducting root cause analysis and implementing preventive measures Implement and maintain security measures to protect systems from unauthorized access and other threats What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of Computer Science, IT or related field experience OR Bachelor’s degree and 6 to 8 years of Computer Science, IT or related field experience OR Diploma and 10 to 12 years of Computer Science, IT or related field experience Preferred Qualifications: Functional Skills: Must-Have Skills Have strong eye for business. Can demonstrate a deep understanding of pharma industry regulations and its compliance requirements Have excellent knowledge of submission publishing systems like Lorenz’s docuBridge application and Disclose from Citeline Have knowledge of ClinicalTrials.gov and EudraCT Have good knowledge of Regulatory Veeva Vault Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent. Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Experience in applying technology standard process methodologiesScaled Agile (SAFe), ITIL, etc. Strong knowledge of information systems and network technologies Good-to-Have Skills: Strong knowledge of eCTD specification and highly regulated (GxP) systems Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle of GxP Systems. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytical/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams (preferred) Veeva Vault platform Certified (preferred) Soft Skills: Excellent analytical and solving skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com

Role Description This is a full-time, on-site role located in Ahmedabad for a Regulatory Affairs professional. The role involves preparing and reviewing regulatory documentation, ensuring compliance with regulatory requirements, coordinating regulatory submissions, and staying updated with evolving regulatory affairs. The candidate will work closely with cross-functional teams to support product registrations and regulatory submissions, ensuring adherence to relevant guidelines and standards. Qualifications Experience in Regulatory Documentation, Regulatory Compliance, Regulatory Requirements Knowledge of Regulatory Affairs and Regulatory Submissions in Europe / ROW / Emerging Market Strong attention to detail and excellent organizational skills Ability to work effectively in a team and coordinate with various departments Excellent written and verbal communication skills Familiarity with pharmaceutical industry regulations is a plus Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field Experience Europe Market - 5-8 Yrs Exp ROW/Emerging Market - 4-12 Yrs Exp Interested candidates can share there resume over mail on krupagohil@unisonpharmaceuticals.com

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? contract conversion Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Job Context: To support MIBG I-131 clinical programs and other JDI innovative products in the pipeline, The Regulatory Specialist will be reporting to the director of Regulatory Affairs and support the development of regulatory strategies related to JDI clinical programs, marketing applications in US and Canada and post-marketing activities. Challenges: 3. SCOPE and SIZE OF THE ROLE (Please indicate key metrics defining the size and scope of the role) Revenue / Operating Budget As per JDI RA budget plans Geographical Responsibilities (Global / International / Country / Area with in Country Will work with the team in Canada and based out of India Area of Impact (Dept. Location / Function or Business / Organization) Regulatory Affairs 4. KEY ACCOUNTABILITIES: ;;;;;;;;;;;;;Accountabilities ;;;;;;;;;;;;;;;;;;;;;;;;;;;Scope of work Regulatory Support Support regulatory due diligence activities pertaining product in-licensing or acquisition (product in clinical development or approved products). Re-evaluate the regulatory strategies following major changes including but not limited formulation, clinical protocol and marketing changes. Participate actively to meetings with regulatory agencies (pre-submission phase, NDA/NDS review phase, post-approval phases) Prepare, review and submit USFDA Investigational New Drug Application (IND) and Health Canada Clinical Trial application (CTA) filings to include but not limited to: new protocols applications, clinical protocol amendments, informed consent forms, clinical summary reports, regulatory correspondences, deviations, safety reports, cost recovery applications, exemptions, CMC amendments. 5. KEY INTERFACES External Interfaces Internal Interfaces Regulatory Agencies Clinical sites, Quality, marketing, clinical, technical services and R and D departments 6. EDUCATION and EXPERIENCE Indicate the education level, previous experience, specific knowledge, skills and abilities required to meet minimum requirements for this Job.. Education Qualification(Highest ) with Target Institute(s) Bachelor's degree in biology, biochemistry, or other life science Desired Certifications : A minimum of 5 years of related experience. Experience Range : 10 - 12 years No. of years post Highest Qualification : 8 years Desirable experience : 10 to 12 Years of Industrial Experience 7. SKILLS REQUIRED: ;;; Skills Description Proficiency Level (General Awareness; Working Knowledge; Functional Expert, Mastery ) Functional Skills Must be detail-oriented with well-developed organizational and analytical skills Functional Expert Behavioral Skills Must be self-motivated, capable of managing multiple projects in a fast-paced environment. General Awareness : Knows the fundamental or general understanding of concepts. Working Knowledge : Has broad job knowledge; knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concept in day to day practices. Functional Expert: Candidate is certified functional expert with strong knowledge on concepts. Mastery: Candidate is subject matter expert and has command over the subject/ concepts.

We have urgent requirement for : Profile : Drug Regulatory Affairs Executive Experience : 2 years to 8 years Location : Nalagarh Skills Required : CTD , ACTD, Dossier Prepration, ACTD, Row Market, Ukraine, Malaysia, Thailand , Mexico etc Interested Candidate can send resume at hr2@theonpharma.com or contact @ 7717304694

Manager Mobility Industrial Join our team in Strategy & Consulting to find endless opportunities and solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Transportation and Logistics, Industrial Consulting, S&C Global Network (GN) I Areas of Work: Mobility & Transport Solutions| Level: Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Explore an Exciting Career at Accenture Are you a problem solver driven by impactful resultsDo you enjoy working on transformation strategies for global clientsDoes a collaborative and inclusive workplace energize you Then, Accenture Strategy & Consulting is where your potential can reach new heights. The Practice A brief Sketch Transportation and Logistics team within S&C GN Industrial Practice brings extensive expertise in driving operational efficiency and digital transformation across global mobility ecosystems. We specialize in digital transformations, end-to-end supply chain optimization, freight and fleet management, route planning and optimization, transportation management systems (TMS) implementation, mobility-as-a-service (MaaS), shared & autonomous mobility services, asset management, process automation and digitization, sustainability initiatives, advanced analytics and data-driven insights, IoT and asset tracking solutions, and industry benchmarking and best practices. Our approach leverages advanced technology to optimize logistics operations, reduce costs, and enhance customer satisfaction, positioning our clients at the forefront of the logistics and transportation industry. Globally, Accenture helps our clients crafting robust transport strategies, driving operational efficiencies, and achieving sustainability goals in logistics. We work on a range of projects, from long-term transformational system integration to short-term agile engagements, supporting our clients with: Mobility Strategy and Transformation: Work with clients to define the vision and roadmap for the future of mobility, focusing on on-demand services, shared & autonomous mobility models, and the seamless integration of mobility services through MaaS platforms. Smart Stations and Terminals Ideation: Lead efforts in designing and developing smart infrastructure solutions for both rail and multimodal hubs that incorporate IoT, digital ticketing, and predictive analytics to improve efficiency, customer experience, and sustainability Enhance Customer Experience: Help clients develop and deploy autonomous rail technologies, on-demand mobility services, multimodal transport systems (e.g., buses, ferries, rail), and high-speed rail systems that enhance flexibility, accessibility, and speed, while improving overall passenger satisfaction and reducing congestion Fleet Electrification: Accelerating adoption of sustainable, electric-powered fleets for various modes of transport including buses and rails, ensuring compliance with environmental regulations Sustainability Mobility :Partner with clients to transition fleets to electric-powered systems, implement energy-efficient routes, and support the adoption of sustainable practices that reduce carbon emissions and ensure compliance with evolving environmental regulations Bring your best skills forward to excel in the role: Skills in one or more of the following areas: Urban Mobility Expertise: In-depth knowledge of multi-modal transport systems (rail, bus, ferry), including high-speed rails, fleet electrification, and shared & autonomous mobility services. Mobility-as-a-Service (MaaS): Experience in integrating on-demand mobility services into existing transport infrastructures, creating seamless connections between multiple modes of transport. Fleet Electrification: Expertise in transitioning fleets (buses, rail) to electric systems, optimizing energy consumption, and reducing emissions. Smart Infrastructure: Knowledge in designing smart infrastructure solutions, smart stations, and bus/ ferry/ air terminals that incorporate the latest digital technologies to enhance efficiency and improve passenger experience. Autonomous and On-Demand Mobility Solutions: Familiarity with the integration of autonomous vehicles and on-demand rail services within existing mobility networks. Sustainability and Green Mobility: Strong understanding of sustainable practices in the rail sector and knowledge of how to implement green mobility strategies in line with industry standards and regulations. Advanced Analytics and IoT Solutions: Ability to leverage IoT, predictive analytics, and data-driven insights to optimize transport operations and asset management. Other required skills: Leadership and Team Development - Ability to lead, mentor, and develop teams, fostering collaboration and creating an environment of growth and continuous learning Stakeholder Management - Manage mid-level to senior client leadership and lead conversations Communication and Presentation - Plan and deliver well-structured oral and written communications Structured Problem Solving - Help identify and structure key client challenges into hypotheses and conduct analyses to address the challenges Program management skill with an ability to coordinate cross-functional teams, manage project timelines, and drive successful delivery within scope and budget Cross-cultural competence with an ability to thrive in a dynamic environment Your experience counts! MBA from a Tier 1 or Tier 2 school, or extensive industry experience in mobility services or consulting. 8+ years of progressive experience in mobility solutions, fleet electrification, and MaaS integration. Experience with smart infrstructure, autonomous mobility, and on-demand services. Certifications in Project Management (e.g., PMP, Prince2) and Agile methodologies are an advantage. Familiarity with Agile practices (e.g., Scrum, Kanban) and tools like JIRA to manage projects effectively. Experience in strategy and business/technology consulting role conversant with process improvement, cost optimization, customer analytics and experience management etc. Experience in value architecting, business case preparation, value realization Experience in Digital, New IT, Cloud & Core modernization, Cloud transformation processes, transforming legacy to the cloud, Agile transformation, RPA, AI/ML strategy implementation and use cases Knowledge of design thinking workshops and innovation Experience in large data analysis, data driven consulting, BI and analytics, reporting, dashboarding, visualization tools like PowerBI, Tableau For Experienced candidates, experience of team Management Coach and mentor team members in projects, on asset development, BDs and overall professional development Whats in it for you An opportunity to work on transformative projects with key G2000 clients Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers, and communities. This is our unique differentiator. S&C Global Network (GN) a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our S&C Global Network (GN) teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. come and be a part of our team. Qualification Years of Exp: 8+ years

Manager Mobility Industrial Join our team in Strategy & Consulting to find endless opportunities and solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Transportation and Logistics, Industrial Consulting, S&C Global Network (GN) I Areas of Work: Mobility & Transport Solutions| Level: Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Explore an Exciting Career at Accenture Are you a problem solver driven by impactful resultsDo you enjoy working on transformation strategies for global clientsDoes a collaborative and inclusive workplace energize you Then, Accenture Strategy & Consulting is where your potential can reach new heights. The Practice A brief Sketch Transportation and Logistics team within S&C GN Industrial Practice brings extensive expertise in driving operational efficiency and digital transformation across global mobility ecosystems. We specialize in digital transformations, end-to-end supply chain optimization, freight and fleet management, route planning and optimization, transportation management systems (TMS) implementation, mobility-as-a-service (MaaS), shared & autonomous mobility services, asset management, process automation and digitization, sustainability initiatives, advanced analytics and data-driven insights, IoT and asset tracking solutions, and industry benchmarking and best practices. Our approach leverages advanced technology to optimize logistics operations, reduce costs, and enhance customer satisfaction, positioning our clients at the forefront of the logistics and transportation industry. Globally, Accenture helps our clients crafting robust transport strategies, driving operational efficiencies, and achieving sustainability goals in logistics. We work on a range of projects, from long-term transformational system integration to short-term agile engagements, supporting our clients with: Mobility Strategy and Transformation: Work with clients to define the vision and roadmap for the future of mobility, focusing on on-demand services, shared & autonomous mobility models, and the seamless integration of mobility services through MaaS platforms. Smart Stations and Terminals Ideation: Lead efforts in designing and developing smart infrastructure solutions for both rail and multimodal hubs that incorporate IoT, digital ticketing, and predictive analytics to improve efficiency, customer experience, and sustainability Enhance Customer Experience: Help clients develop and deploy autonomous rail technologies, on-demand mobility services, multimodal transport systems (e.g., buses, ferries, rail), and high-speed rail systems that enhance flexibility, accessibility, and speed, while improving overall passenger satisfaction and reducing congestion Fleet Electrification: Accelerating adoption of sustainable, electric-powered fleets for various modes of transport including buses and rails, ensuring compliance with environmental regulations Sustainability Mobility :Partner with clients to transition fleets to electric-powered systems, implement energy-efficient routes, and support the adoption of sustainable practices that reduce carbon emissions and ensure compliance with evolving environmental regulations Bring your best skills forward to excel in the role: Skills in one or more of the following areas: Urban Mobility Expertise: In-depth knowledge of multi-modal transport systems (rail, bus, ferry), including high-speed rails, fleet electrification, and shared & autonomous mobility services. Mobility-as-a-Service (MaaS): Experience in integrating on-demand mobility services into existing transport infrastructures, creating seamless connections between multiple modes of transport. Fleet Electrification: Expertise in transitioning fleets (buses, rail) to electric systems, optimizing energy consumption, and reducing emissions. Smart Infrastructure: Knowledge in designing smart infrastructure solutions, smart stations, and bus/ ferry/ air terminals that incorporate the latest digital technologies to enhance efficiency and improve passenger experience. Autonomous and On-Demand Mobility Solutions: Familiarity with the integration of autonomous vehicles and on-demand rail services within existing mobility networks. Sustainability and Green Mobility: Strong understanding of sustainable practices in the rail sector and knowledge of how to implement green mobility strategies in line with industry standards and regulations. Advanced Analytics and IoT Solutions: Ability to leverage IoT, predictive analytics, and data-driven insights to optimize transport operations and asset management. Other required skills: Leadership and Team Development - Ability to lead, mentor, and develop teams, fostering collaboration and creating an environment of growth and continuous learning Stakeholder Management - Manage mid-level to senior client leadership and lead conversations Communication and Presentation - Plan and deliver well-structured oral and written communications Structured Problem Solving - Help identify and structure key client challenges into hypotheses and conduct analyses to address the challenges Program management skill with an ability to coordinate cross-functional teams, manage project timelines, and drive successful delivery within scope and budget Cross-cultural competence with an ability to thrive in a dynamic environment Your experience counts! MBA from a Tier 1 or Tier 2 school, or extensive industry experience in mobility services or consulting. 8+ years of progressive experience in mobility solutions, fleet electrification, and MaaS integration. Experience with smart infrstructure, autonomous mobility, and on-demand services. Certifications in Project Management (e.g., PMP, Prince2) and Agile methodologies are an advantage. Familiarity with Agile practices (e.g., Scrum, Kanban) and tools like JIRA to manage projects effectively. Experience in strategy and business/technology consulting role conversant with process improvement, cost optimization, customer analytics and experience management etc. Experience in value architecting, business case preparation, value realization Experience in Digital, New IT, Cloud & Core modernization, Cloud transformation processes, transforming legacy to the cloud, Agile transformation, RPA, AI/ML strategy implementation and use cases Knowledge of design thinking workshops and innovation Experience in large data analysis, data driven consulting, BI and analytics, reporting, dashboarding, visualization tools like PowerBI, Tableau For Experienced candidates, experience of team Management Coach and mentor team members in projects, on asset development, BDs and overall professional development Whats in it for you An opportunity to work on transformative projects with key G2000 clients Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers, and communities. This is our unique differentiator. S&C Global Network (GN) a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our S&C Global Network (GN) teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. come and be a part of our team. Qualification Years of Exp: 8+ years

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Adaptable and flexibleCommitment to qualityHands-on experience with trouble-shootingAgility for quick learningAbility to work well in a team Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications are optimized for performance and usability. You will also participate in testing and debugging processes to ensure the applications function as intended, while continuously seeking ways to enhance application efficiency and user experience. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure timely delivery of application features. Professional & Technical Skills: - Must To Have Skills: Proficiency in Lorenz docuBridge or other regulatory submission & publishing management system.- Experience in supporting Publishing applications- Experience in working in Lorenz docuBridge- Must have functional & technical skill in regulatory publishing systems.- Strong domain knowledge & understanding of application design principles and best practices.- Ability to troubleshoot and resolve technical issues effectively.- Familiarity with integration of Lorenz docuBridge with other enterprise systems. Additional Information:- The candidate should have minimum 3 years of experience in Lorenz docuBridge or similar document systesms.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

Project Role :Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Oracle Applications Development Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : BTech or MTech or MCA with IT or CSE or EEE or ECE15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with various teams to understand their needs, developing solutions that align with business objectives, and ensuring that applications are optimized for performance and usability. You will also engage in problem-solving activities, providing support and enhancements to existing applications while maintaining a focus on quality and efficiency. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure timely delivery of application features. Professional & Technical Skills: - Must To Have Skills: Proficiency in Oracle Applications Development.- Good To Have Skills: Experience with Oracle Cloud applications.- Strong understanding of application lifecycle management.- Familiarity with programming languages such as Java or PL/SQL.- Experience in integrating applications with third-party services. Additional Information:- The candidate should have minimum 5 years of experience in Oracle Applications Development.- This position is based at our Hyderabad office.- A BTech or MTech or MCA with IT or CSE or EEE or ECE is required. Qualification BTech or MTech or MCA with IT or CSE or EEE or ECE15 years full time education

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Advanced About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Adaptable and flexibleProblem-solving skillsAgility for quick learningStrong analytical skillsAbility to meet deadlines Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards not to mention various social and recreational activities, all of which are location specific. Job description What you will do Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource. Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work. Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature. Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes. Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products. Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications. Determining and communicating submission and approval requirements. What you need: Required- Bachelor's or Masters degree in Regulatory Affairs, Engineering or equivalent discipline is required. 3 - 5 years experience Preferred- Experience with post-market and change management is a distinct advantage RAC Certification is preferred

• Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market • Preparation of query response of drug substance for various and less regulated markets and customers. • Preparation of applicant part and closed part for various authorities for different customers. • Preparation of annual updates and amendment of drug master files US via ESG, ASMF via CESP, KDMF via MFDS Korea, • Preparation and submission of CEP applications and responses to EDQM via CESP. • Preparation of CEP LOAs & LOA’s and declarations of various customers and authority. • To collect and evaluate scientific data for assessment and prepare regulatory submission for authorities and customers

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Master of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? Agility for quick learningAdaptable and flexibleAbility to work well in a teamAbility to perform under pressureAbility to meet deadlines Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? Agility for quick learningAdaptable and flexibleAbility to work well in a teamAbility to perform under pressureAbility to meet deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

RESPONSIBILITIES Author high- quality CMC documentation for US FDA submissions for Post approval supplements/Annual reports in accordance with latest guidance assuring technical congruency and regulatory compliance. Tracking labeling updates and handle corresponding CBE-0 filing. Provide support in PADER submissions. Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends Co-ordination with stakeholders on a regular basis to extend all technical support required from regulatory perspective DESIRED SKILLS Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle. Good technical knowledge, review skills and understanding of regulatory submissions. Strong knowledge of CTD /eCTD requirements for submission of dossiers. Ability to try new approaches when faced with challenges. Should have good analytical and learning attitude.

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationBangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitting regulatory applications such as permits, licenses, certificates and authorization required by governmental agencies Coordinating government interactions and compliance activities; and interacts with regulatory agencies What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Support the RTB team lead in protecting DB from legal, regulatory and reputational risk with regard to business involving sanctioned entities and / or countries. Ensure diligent review and confirmation of transactions that require escalation to a Level 2 investigator and decide on these in full compliance with the applicable Sanctions regulations and the banks policies and procedures. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Convert timely the update of the relevant embargo lists in respective filtering systems implement the data to central and decentralized tools in GT and Operations. Support CoC Regulatory Filtering team on the adoption of new clients Your Key Accountabilities RTB focus Primarily review stopped messages and take a decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Record rationale for decision from pre-defined set of options. Seek feedback from more senior investigators/reviewers, where their decisions fail the four-eye control. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorised purposes; actively safeguard sensitive and confidential information. CTB focus Supports TSMO / AFC related change projects Supports remediation actions owned by TSMO / AFC Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleAgility for quick learningWritten and verbal communicationAbility to work well in a teamResults orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation