202 Ectd Jobs

We are seeking an experienced Regulatory Affairs professional to support and manage the regulatory lifecycle of oral solid dosage (OSD) products across key global markets, including the EU, USA, and RoW.

Our Ideal Candidate: Our ideal candidate will typically be expected to demonstrate the following attributes: Good technical knowledge in Oracle Cloud Infrastructure Knowledge & working experience in ExaCS Understanding of Technical architecture landscape Should have a strong customer facing skills Ability to multitask, maintain composure in high-stress/high-visibility situations and change priority as needed to accommodate very dynamic business. Excellent team player, willing to learn new technologies Strong organization skills, detail oriented & communication skills. . University degree, with post graduate technical or management qualifications or other relevant experience. OCI Certified / ITIL Foundation Certification in IT Service Management Responsibilities Your Qualifications: The candidate should have 12+ years of IT experience which includes Service Delivery Management experience and have a track record in collaborating with large-scale global teams. High commitment with his/her customers is must. The role will be based out of Bangalore/NCR/Mumbai Your Responsibilities Key tasks include, but are not limited to, the following: SCOPE: Manage service delivery activities for customers Oracle Cloud Infrastructure setup Represent as a single point of contact between customer & Oracle. Manage the service delivery through virtual team of resources from multiple XLOBs Establish priorities & Service growth plans for customers aligned to Oracles Cloud Strategy. ACCOUNTABILITIES Customer handover from Service Desk & Customer Introduction Schedule & Deliver Service Kickoff with Customer & Internal Stakeholders Prepare the Joint Contact & Escalation Guide (JC&EG) Request for Cloud Delivery Architect (CDA) to be assigned for Discovery of customer environment in OCI CSS Problem Management Notification Customer Information Setup in Fusion CX (Internal tool) Digital Learning My Learn Admin Account Setup RESPONSIBILITIES Prepare & deliver Monthly Service Reviews to customer Monthly Incident Analysis Reports Trend Analysis & Status of Remediation Deliver Quarterly SVRs Act as Incident Communicator during Major Incidents Join/Co-host External War Room with Service Desk and customer Responsible for sharing RCA with customer & Remediation follow-up Responsible to track & Report Digital Learning Consumption in OCI Analyze OCI cost consumption data and report findings to customer Coordinate with XLOBs during any Major incidents to drive incident resolution Issue and Risk Management Escalation Management Technical Expertise: Oracle Cloud Infrastructure Knowledge: Proficient in Oracle Cloud Infrastructure. Experienced in ExaCS. Knowhow of OCI network architecture Tech Skills: MAA, Disaster Recovery, Security, Backups, Compliance, Capacity Planning Oracle Cloud Certification: Foundation, Associate Architect Soft Skills: Able to consider diverse perspectives Ability to articulate and translate customer needs into solutions. Demonstrates creativity and innovativeness. Stakeholder management: Strong ability to manage stakeholders effectively. Customer management: Strong ability to manage customer expectations Excellent communication abilities Ability to communicate with virtual XLOB team(s) Ability to lead and drive technical discussions related to Oracle Cloud Infrastructure

SUMMARY Purpose of Job: Support the effective management of company assets throughout their lifecycle, ensuring accuracy, accountability, and compliance. The role focuses on maintaining updated asset records, monitoring utilization, and assisting in the reconciliation of fixed and movable assets. The position is responsible for providing timely and accurate asset-related data to management; assisting in audits. Job Description: Through Google Sheet operate CAPEX PR & PO. Maintain equipment details. Maintain vendor service PO. It is maintained totally through Google Sheet with a variety of reports. Good knowledge of Excel, Word & PowerPoint. Requirements Required relevant experience (Type and Nature) Hands-on exposure to asset tracking systems, advanced MS Office, or asset management tools . Experience in monitoring, recording, and reconciling fixed assets . Practical experience in coordinating with procurement, finance, and operations teams for asset lifecycle management. Experience in asset management, inventory control, or finance-related roles . Technical competency and skill required to execute the role Proficiency in asset tracking, tagging, and lifecycle management . Ability to maintain and reconcile asset registers, depreciation schedules, and disposal records . Familiarity with advanced MS Office (Excel, Word, PowerPoint) . Competence in variance analysis, MIS reporting, and asset reconciliation . Ability to prepare asset utilization and cost-benefit analysis reports . Ability to generate dashboards and reports for management decision-making . Knowledge of inventory control methods .

We're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting. Strong experience in US FDA regulations and ICH guidelines. Experience in handling pre- and post-approval submissions is required Interested candidates can share their resumes on sheetal.na@peoplefy.com

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Associate Qualifications: Any Graduation Years of Experience: 1 to 3 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? 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

Role & responsibilities Regulatory Strategy Development : Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these regions. Identify regulatory pathways for new product launches and lifecycle management of existing products. Regulatory Submissions and Approvals : Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for injectables across multiple jurisdictions (e.g., Africa, CIS, LATAM). Coordinate and manage the submission of regulatory documents (CTDs, eCTDs, dossiers, clinical trial applications) to the relevant health authorities. Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines. Compliance Management : Ensure that all pharmaceutical products (particularly injectables) comply with regulatory requirements in target markets across ROW. Review product labeling, packaging, and advertising materials to ensure compliance with local regulatory guidelines. Manage post-market surveillance requirements, including reporting adverse events (AEs), product recalls, or any regulatory non-compliance in the region. Cross-functional Collaboration : Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle. Provide regulatory input and support during the product development phase, particularly for injectables, which often require more complex regulatory scrutiny. Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements. Regulatory Intelligence : Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice), GxP, and other relevant policies across various countries in ROW. Act as the internal subject matter expert on regulatory issues related to injectables in ROW markets. Monitor competitor activities and regulatory trends in the ROW regions, particularly for injectables. Regulatory Affairs Leadership : Lead and manage a team of regulatory professionals across the ROW regions, guiding their work in regulatory submissions and compliance activities. Provide mentoring and training to team members to enhance their regulatory knowledge and skills, particularly in the injectables segment. Risk Management & Problem Solving : Identify and mitigate regulatory risks related to the approval process for injectables in target regions. Address regulatory challenges or delays and take proactive steps to resolve issues, including negotiating with health authorities or addressing deficiencies in submissions. Regulatory Advocacy and Relationship Management : Build and maintain strong relationships with key regulatory authorities in various ROW regions, including ministries of health, regulatory bodies, and industry associations. Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations and injectables. Documentation & Reporting : Maintain accurate and comprehensive regulatory files and documentation for products, especially injectables, in compliance with regional regulations. Provide regular updates to senior management on regulatory milestones, challenges, and market access status. Preferred candidate profile Must have experience into injectables dosage forms.

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficiency responses and/or post-approval submissions for above markets. Worked on various dosage forms including complex generics. Compilation of Module 2 and 3 CTD sections for above submissions. Review of documents for all these sections. Knowleage of ICH as well as country specific guidance for documents to be submitted in all above sections. Hands on experiance for ECTD compilation. Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent Education Masters Graduation in Pharmacy or Science

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa. Support product registrations, renewals & variations. Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management. Respond to health authority queries in coordination with CMC, clinical, and quality teams. Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines. Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc. Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines. Experience working with local affiliates or partner companies in Emerging Markets. Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc. Experience with regional electronic submission platforms. Qualifications: Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, or related field. Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets. Knowledge of CTD structure, Module 1 customization, and regional submission formats. Strong project management, communication, and stakeholder coordination skills Show more Show less

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Oracle Utilities Customer to Meter C2M SPL Good to have skills : NA Minimum 2 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 function seamlessly to support organizational goals. You will also participate in testing and troubleshooting to enhance application performance and user experience, contributing to the overall success of the projects you are involved in. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Assist in the documentation of application processes and workflows.- Engage in continuous learning to stay updated with industry trends and technologies. Professional & Technical Skills: - Must To Have Skills: Proficiency in Oracle Utilities Customer to Meter C2M SPL.- Strong analytical and problem-solving skills.- Experience with application development methodologies.- Familiarity with database management and SQL.- Ability to work collaboratively in a team environment. Additional Information:- The candidate should have minimum 2 years of experience in Oracle Utilities Customer to Meter C2M SPL.- This position is based at our Noida office.- A 15 years full time education is required. Qualification 15 years full time education

About The Role Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 year 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? 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 relationsYou will be expected to 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? Looking for the candidate with Good Communication and written skills, any degree expect B.tech/B.E 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

About The Role Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years 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? 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 relationsYou will be expected to 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? Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures The person requires understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor or team leads Generally interacts with peers and/or management levels at a client and/or within Accenture The person should require minimal guidance when determining methods and procedures on new assignments Decisions often impact the team in which they reside and occasionally impact other teams Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP Asset Management Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that the applications are aligned with business objectives and user needs, while maintaining a focus on quality and efficiency throughout the project lifecycle. 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 milestones. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP Asset Management.- Good To Have Skills: Experience with SAP S/4HANA.- Strong understanding of application lifecycle management.- Experience in integrating SAP Asset Management with other enterprise systems.- Familiarity with agile methodologies and project management tools. Additional Information:- The candidate should have minimum 5 years of experience in SAP Asset Management.- This position is based at our Hyderabad office.- A 15 years full time education is required. Qualification 15 years full time education

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years 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? 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 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 Any Graduation

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years 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? 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

Location: Gurgaon Regulatory and Safety Affairs is a critical function within R&D: a key partner in developing the right portfolio strategy for brilliant innovation, activation in our markets and secure the products during all product life cycle. We actively engage externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment, and we bring that regulatory intelligence back to Reckitt to drive better informed business decisions. We lead the thinking internally about what is possible and put forward ideas that become reality, acting as stewards of our brands and our company to deliver compliant and competitively positioned products to the people we serve. Data, and data accuracy Is a foundational element of regulatory processes and directly influences the effectiveness of the organisation and its ability to deliver compliant and competitively positioned products. As Regulatory Operations Specialist Publishing you will be responsible for the compilation and publishing of all regulatory data packages required across the product lifecycle stages, initially focused on the global medicinal portfolio and will reach further into other classifications once established. In your role you will be responsible for the quality, accuracy, and timely population of data within the key business systems which support publishing activities. You will become a subject matter expert in the use of these systems and the business processes which support them. You will partner with the wider Operations Regulatory team to understand and meet its publishing needs. You will lead reviews with the wider Operations Regulatory team to feed back on publishing activities ensuring we deliver to key stakeholders in areas such as accuracy, timeliness etc. Where required, and in conjunction with the wider Operations Regulatory teams, you will use continuous improvement methodology to improve internal business processes and systems which support Publishing activities. You are proficient in the field of publishing, and you will use your experience to execute your role effectively and to a high level of compliance with the applicable standards and external industry expectations. You will play an important role because. We’re proud of our organisation and continually strive to be the best that we can be. The Regulatory Operations - Publishing plays an essential role in leading a team that deliver critical services to the broader Regulatory Operations function. You will succeed because ... You bring prior experience in the field of regulatory publishing, with a strong track record of successful delivery. You are skilled in the identification of key stakeholders and have a strong capability for building mutually beneficial partnerships based on openness and transparency. Have good communication skills and capability to keep key stakeholders consistently informed and updated across a broad range of subjects and processes in real time. You have broad knowledge of regulatory processes, with particular emphasis on medicines, but experience in other classifications is considered beneficial. You have knowledge of the medicinal dossier structure and regulations / guidance for global markets, medicinal publishing requirements, document repositories, common validation publishing challenges, and management of sequences and submission tracking throughout the product lifecycle. You will have knowledge of the worldwide publishing standards including, Nees, ACTD, eCTD, US, Swiss and South Africa Have knowledge or experience in the use of publishing tools / solutions such as Lorenz Documbridge etc. Ability to consistently deliver to time, cost and quality standards in a high-pressure environment. Demonstrates courage and empathy and work collaborative cross-functional, through change by adopting a growth and compliance mindset and inclusive/expansive leadership. Key Responsibilities of the Role will include Responsible for delivering all publishing activities on time and to a high-quality standard. All publishing activities includes: collating all required documents, compilation, validation of all modules and publishing of the dossier/ensuring the submission package is ready for publishing. Fostering productive relationships with those stakeholders critical to your role and maintaining high level of communication to ensure buy in and engagement. You will apply the principles of continuous improvement to consistently and critically review internal processes to identify and deliver increased efficiency, compliance or other business benefit. Training your publishing team to a high level of knowledge and competency in publishing processes. Deliver regular updates on work deliveries, transparency in the execution plans and dates, project management alongside reg ops teams.

Job Description: Job Title: Regulatory Filtering Analyst Corporate Title: NCT Location: Bangalore, 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 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

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 any graduation 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

Key Responsibilities Prepare, review, and submit CTD/ACTD/eCTD dossiers for international markets Develop and execute regulatory strategies for ROW, LATAM, SEA, Africa, and Pacific regions Manage product registration, renewals, variations, and post-approval compliance Ensure compliance with WHO-GMP, ICH, and country-specific regulatory guidelines Coordinate bioequivalence studies and relevant documentation Review technical files and maintain up-to-date regulatory documentation Liaise with regulatory authorities, internal departments, and external partners Mentor junior RA team members and drive process improvements Requirements B.Pharm / M.Pharm / Life Sciences background Minimum 6 years experience in Regulatory Affairs within the pharmaceutical industry Proficient in CTD/ACTD/eCTD dossier compilation Experience with parenteral dossiers (preferred) Exposure to global regulatory submissions and product lifecycle management Proficient in MS Office, with strong communication and leadership skills

Role & Responsibilities: Ensure compliance with applicable laws, regulations, and guidelines related to the company's products or services. Regulatory Submissions: Prepare, review, and submit regulatory documents to relevant authorities, such as product registrations, notifications. Documentation Management: Maintain accurate and up-to-date regulatory documentation, including product technical files, labeling, and manufacturing records. Collaborate with cross-functional teams to provide regulatory guidance and support during product development stages. Review product specifications and documentation to ensure compliance. Regulatory Liaison: Communicate and interact with regulatory authorities or third-party consultants to address inquiries, resolve issues, or obtain necessary approvals. Regulatory Audits: Assist in preparing for and participating in regulatory audits or inspections. Address any findings or observations and implement corrective actions. Quality Assurance: Participate in quality assurance activities, including conducting internal audits, implementing corrective and preventive actions, and ensuring compliance with quality standards. Risk Management: Assess and mitigate regulatory risks associated with product compliance, labeling, advertising, or post-market surveillance. Cross-functional Collaboration: Collaborate with various departments, such as QA,QC R&D, and marketing, to ensure alignment with regulatory requirements. Regulatory Reporting: Prepare periodic reports on regulatory activities, metrics, or performance indicators for management or regulatory authorities.

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 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

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP Asset Management Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that the applications are aligned with business objectives and user needs, while maintaining a focus on quality and efficiency throughout the project lifecycle. 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 milestones. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP Asset Management.- Good To Have Skills: Experience with SAP S/4HANA.- Strong understanding of application lifecycle management.- Experience in integrating SAP Asset Management with other enterprise systems.- Familiarity with agile methodologies and project management tools. Additional Information:- The candidate should have minimum 5 years of experience in SAP Asset Management.- This position is based at our Hyderabad office.- A 15 years full time education is required. Qualification 15 years full time education

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: BCom/B.B.M 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? Looking for a resource with Medicare Enrollment processing experience or a fresher. Ready to work in US shift time. Ready to work under stringent case timelines 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 BCom,B.B.M

SUMMARY Purpose of Job: Support the effective management of company assets throughout their lifecycle, ensuring accuracy, accountability, and compliance. The role focuses on maintaining updated asset records, monitoring utilization, and assisting in the reconciliation of fixed and movable assets. The position is responsible for providing timely and accurate asset-related data to management; assisting in audits. Job Description: Through Google Sheet operate CAPEX PR & PO. Maintain equipment details. Maintain vendor service PO. It is maintained totally through Google Sheet with a variety of reports. Good knowledge of Excel, Word & PowerPoint. Requirements Required relevant experience (Type and Nature) Hands-on exposure to asset tracking systems, advanced MS Office, or asset management tools . Experience in monitoring, recording, and reconciling fixed assets . Practical experience in coordinating with procurement, finance, and operations teams for asset lifecycle management. Experience in asset management, inventory control, or finance-related roles . Technical competency and skill required to execute the role Proficiency in asset tracking, tagging, and lifecycle management . Ability to maintain and reconcile asset registers, depreciation schedules, and disposal records . Familiarity with advanced MS Office (Excel, Word, PowerPoint) . Competence in variance analysis, MIS reporting, and asset reconciliation . Ability to prepare asset utilization and cost-benefit analysis reports . Ability to generate dashboards and reports for management decision-making . Knowledge of inventory control methods .

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy 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 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 Ability to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexibleAgility for quick learning 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 Bachelor of Pharmacy,Master of Pharmacy

International Solar Alliance is looking for REGULATORY SPECIALIST to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistants, specialists, therapists, and other medical staff. Advising patients, parents, and guardians on diets, activities, hygiene, and disease prevention. Conducting research and remaining up to date on current trends, discoveries, and developments in the field