117 Ectd Jobs

Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia, the Middle East, and the rest of Asia-Pacific. Recognized by Great Place to Work in India, Chile, Romania, the US, and the UK in 2022, we offer a dynamic, growth-oriented, and meritocracy-based culture that prioritizes continuous learning and skill development, work-life balance, and equal opportunity for all. Curious to know what its like to work at Evalueserve? Read on. About Investment Research (IR) As a global leader in knowledge processes, research, and analytics, youll be working with a team that specializes in global market research, working with the top-rated investment research organizations, bulge bracket investment banks, and leading asset managers. We cater to 8 of the top 10 global banks, working alongside their product and sector teams, supporting them on deal origination, execution, valuation, and transaction advisory-related projects. What you will be doing at Evalueserve Work directlywith the head of the team, who has been consistently ranked as the top analystin CEEMEA strategy by several top-tier investment banks. Handle research, strategy, and analytics for all EM fixed income-related products offered by theresearch platform of the banking client. Conduct macroeconomicand market research across emerging markets. Develop andmaintain financial models and analytical frameworks for EM fixed incomeproducts. Analyze largedatasets to identify market trends and investment opportunities. Support theteam in producing high-quality research reports and market commentary. Collaboratewith trading, sales, and risk teams to align strategy insights with businessneeds. Utilize toolssuch as Bloomberg, Macrobond, and Haver, and IMF databases for data extractionand analysis. What were looking for: Advanceddegree in economics /statistics /engineering with minimum relevant experienceof 3 years. Progress towards CFA / FRM is preferable. Priorexperience of macro research, financial modeling, structuring, trading, ormarket risk management Keen interestin global financial markets and knowledge of recent developments. Strongquantitative and mathematical skills with experience of working with largeamounts of data. AdvancedExcel, VBA analytical skills, and knowledge of basic econometrics is a must.Working knowledge of Python or R will be considered a plus. Excellentwritten and verbal communication skills ability to write research reports andcomment on market developments. Knowledge ofdatabase tools Bloomberg, Macrobond, Haver, World Bank, IMF, etc. Follow us on https://www.linkedin.com/compan y/evalueserve/ Click here to learn more about what our Leaders talking on achievements AI-powered supply chain optimization solution built on Google Cloud. How Evalueserve is now Leveraging NVIDIA NIM to enhance our AI and digital transformation solutions and to accelerate AI Capabilities . Know more about how Evalueserve has climbed 16 places on the 50 Best Firms for Data Scientists in 2024! Want to learn more about our culture and what its like to work with us? Write to us at: careers@evalueserve.com Disclaimer: The following job description serves as an informative reference for the tasks you may be required to perform. However, it does not constitute an integral component of your employment agreement and is subject to periodic modifications to align with evolving circumstances. Please Note: We appreciate the accuracy and authenticity of the information you provide, as it plays a key role in your candidacy. As part of the Background Verification Process, we verify your employment, education, and personal details. Please ensure all information is factual and submitted on time. For any assistance, your TA SPOC is available to support you.

Summary Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements Ensures compliance to the requirements from regulatory agencies Maintains the technical and non-technical documentation change system Assures procedures are in place to classify and maintain records Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers, About The Role Key Responsibilities Structured Data Submissions (SDS): Independently perform timely SDS ( e-g xEVMPD, IDMP) via RIM system, ensuring data quality and exchange with EMA including analysis and tracking of 3rd acknowledgements Ensure Data Quality Management and timely delivery of requests for new/changes of code lists/terms including external reference data ( e-g SPOR), Provide guidance and support to cross-functional teams related to planning, submission compilation and dispatch of worldwide compliant SDS, as well as submission filing strategy, eCTD document lifecycle management and workflows, in alignment with FHIR (Fast Healthcare Interoperability Resources) Assess SDS resources and support needs and develop/implement solutions to create efficiencies Effectively troubleshoot technical/quality issues relating to compilation, validation and dispatch of global submission outputs, Coding of Clinical Particulars: Perform coding of the Clinical Particulars attributes in Novartis Regulatory Information Management (RIM) system: Therapeutic Indications and Co-morbidity using the MedDRA dictionary, Intended effect using a controlled vocabulary, as required to ensure compliance with xEVMPD / IDMP requirements, Review and maintain MedDRA code values used in EU registrations upon MedDRA version updates by performing gap analysis of changes, and update existing values accordingly in RIM system Review and update coding values as needed upon queries from the European Medicines Agency (EMA), for instance receipt of 3rd acknowledgment, Interactions: Liaise with GDD colleagues regarding new regulatory requirements and related business processes, to ensure proper knowledge transfer to IT business partners for system enhancement requests, Manage interactions and collaboration with RA Country Organisations (CO), Global RA and non-RA functions on regulatory and compliance maintenance activities for Authorised and Investigational medicinal products, Optimally support QPPV and PV-related processes (incl fees), provide support for internal /external audits /inspections Facilitate and/or participate in meetings with internal and external stakeholders (including acquisitions, partnerships and divestiture efforts) Participate as key business contributor in Technology initiatives including, but not limited to, systems upgrades, validation, implementation activities and functionality enhancements, including external service providers, General & Training: Support user training of RA end users, as required, Coach / mentor new team members Support PQ testing and Application verification activities, as required Support preparation of administrative procedures and Working Instructions to support system implementations Develop, implement, and support innovative regulatory strategies and life-cycle management of RA systems, including process productivity and efficiency improvement and propose potential solutions Identify and investigate operational needs, problems, and opportunities, contribute to the implementation of improvements within area of responsibility, Minimum Requirements BS in Life Sciences (Medicines/Pharmacy) or a relevant discipline with at least 7 years of professional work experience Masters degree preferred (M Pharma or MD), 4-6 years of relevant experience in structured data submissions ( e-g xEVMPD) and use of RIM systems, including familiarity with submission publishing activities, 3-5 years in Clinical coding ( e-g MedDRA, SNOMED), Labelling, Regulatory Affairs or Regulatory submission related experience WITH SDS experience as 1st bullet, Proficient knowledge of EMAs databases ( e-g SPOR), Knowledge and experience with eCTD, xEVMPD, IDMP, Publishing Standards and applicable related tools is desirable, Experienced in using RA systems of data (RIMS, DMS, Change Control databases), systemsdata model and vocabularies Familiar with the drug development and registration process, Solid project management, organizational and time management skills to manage multiple ongoing projects simultaneously, Familiar with global Health Authority regulations/guidelines e-g , FDA regulations, ICH and EMA guidelines/directives, Proficiency with computer programs/systems (MS office, etc) with demonstrated ability to learn new systems quickly Strong analytical skills and problem-solving skills Ability to coordinate and work effectively with cross-functional teams Why Novartis: Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world How can we achieve thisWith our people It is our associates that drive us each day to reach our ambitions Be a part of this mission and join us! Learn more here: https:// novartis / about / strategy / people-and-culture Youll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https:// novartis /careers/benefits-rewards Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve, Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl india@novartis and let us know the nature of your request and your contact information Please include the job requisition number in your message Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork novartis /network Why Novartis: Helping people with disease and their families takes more than innovative science It takes a community of smart, passionate people like you Collaborating, supporting and inspiring each other Combining to achieve breakthroughs that change patientslives Ready to create a brighter future togetherhttps:// novartis / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for youSign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork novartis /network Benefits and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: https:// novartis /careers/benefits-rewards Show

Job Purpose and Impact The Business Analyst - HR Core will lead efforts through influence that will enable change in an organizational context through the creation of the definition of the business needs and the creation of solution recommendations that deliver value to stakeholders. In this role, you will use advanced knowledge of the tasks and techniques that are used to perform complex business analysis such as solution evaluation, strategy analysis, elicitation and collaboration, requirement life cycle management, requirements analysis and design definitions and business analysis planning and monitoring to advance the profitability or efficiency of the business. You will partner effectively with all levels of the organization, guide others, drive results, proactively identify and resolve problems and make challenging decisions to improve business performance. Key Accountabilities Facilitate requirements gathering sessions with business stakeholders, document requirements and create initiatives that support the business requirements and needs. Identify and effectively articulate the need for change in how the organization works and facilitate change applying change management methodologies. Identify and define the solutions to complex business problems that will maximize the value delivered to stakeholders. Guide the business through unknown or unmapped territory to advance to the desired destination as the liaison to cross functional, regional and global solutions delivery teams. Use a thorough comprehension of complex internal or external business issues to analyze the organization or business domain and document business, data, processes or systems and provide an assessment of the business model and the integration with technology. Create test scripts using a traceability matrix tied back to requirements and assist in management of user acceptance testing cycles. Collaborate across all levels of the organization to collect information about an organizations operations to improve systems and processes, research business processes, analyze the potential impact and create and effectively communicate recommendations for the leadership team. Independently handle complex issues with minimal supervision, while escalating only the most complex issues to appropriate staff. Partner to evolve the capability associated with the process and technology, identify opportunities to optimize processes for improved user experience and conduct regular reviews of standards and success measures. Qualifications MINIMUM QUALIFICATIONS: Bachelors degree in a related field or equivalent experience. Minimum of four years of related work experience. Other minimum qualifications may apply. PREFERRED QUALIFICATIONS: 3+ years experience in SuccessFactors Employee Central (any other modules a plus). Experience in Human Resources with core processes. Certified Six Sigma (green / yellow belt) and / or Kaizen. Identify and define solutions to moderately complex business problems that will maximize the value delivered to stakeholders. Support implementation of the operating model of a domain process by collaborating closely with human resources leaders to drive continuous improvement across the assigned domain. Support implementation of programs to build process and technology capability, identify opportunities to optimize processes for improved user experience and participate in regular reviews of standards and success measures.

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Contract Management Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations, and integrations, and can guide others in leveraging it effectively. Must have skills:3+ years of Cobblestone or similar Conract life cycle management tool hands on experience High analytical skills to understand and implement the requirementsGood communication and ability to handle client and cross team communications independently and effectively Ability to create meaningful requirement and status documentation in client specific formatFunctional testing knowledge Good to have:Certification in cobblestone or IcertisHealthcare Domain knowledge Qualification 15 years full time education

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 : Contract Management Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations, and integrations, and can guide others in leveraging it effectively. Must have skills:3+ years of Cobblestone or similar Conract life cycle management tool hands on experience High analytical skills to understand and implement the requirementsGood communication and ability to handle client and cross team communications independently and effectively Ability to create meaningful requirement and status documentation in client specific formatFunctional testing knowledge Good to have:Certification in cobblestone or IcertisHealthcare Domain knowledge Qualification 15 years full time education

Key Responsibilities: Dossier Compilation: Prepare, compile, and review regulatory submissions (CTD/ACTD format) for ROW & emerging markets. Work on Module 1 (administrative/legal), Module 2 (summaries), and Module 3 (quality) for OSD products. Ensure dossier accuracy, completeness, and alignment with country-specific requirements. Regulatory Compliance: Ensure all documentation complies with ICH , WHO , and respective country-specific guidelines . Maintain awareness of evolving regulatory requirements across ROW markets. Coordination & Liaison: Coordinate with internal teams: QA, QC, Production, Packaging, and F&D for data collation. Liaise with external stakeholders like regulatory consultants and agents for submissions and queries. Product Lifecycle Management: Manage variations, renewals, query responses, and product registration maintenance. Handle change control and post-approval regulatory activities. Document Control: Maintain updated regulatory records and submission trackers. Ensure timely and organized archiving of all submitted dossiers and correspondence.

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs 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 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 sBachelor Degree in Life Sciences 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

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

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 for Oil & Gas Joint Venture Accounting Good to have skills : NAMinimum 12 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 solutions are effectively implemented across multiple teams, while maintaining a focus on quality and efficiency in application delivery. 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.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure alignment with strategic goals. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP for Oil & Gas Joint Venture Accounting.- Strong understanding of financial accounting principles and practices.- Experience with application lifecycle management.- Ability to analyze and optimize business processes.- Familiarity with integration techniques for various applications. Additional Information:- The candidate should have minimum 12 years of experience in SAP for Oil & Gas Joint Venture Accounting.- This position is based at our Hyderabad office.- A 15 years full time education is required. Qualification 15 years full time education

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 : Document Management Systems (DMS) 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 project milestones are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also engage in strategic planning sessions to align project goals with organizational objectives, ensuring that the applications developed meet the needs of stakeholders and users alike. Your role will require you to balance technical oversight with team management, fostering an environment of innovation and collaboration. 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 5 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

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must have exposure to in-licensed dossier filing and out licensing

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization. JOB RESPONSIBILITIES : ;;;;;;;;;;;;; Accountabilities;;;;;;;;;;;;;;;;;;;;;;;;;;; Scope of work US Drug Dossier Authoring, Reviewing and Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation and Submission Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan and complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination Interface with R and D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R and D/ADL against DMF/Dossier requirements Reporting and Maintenance Maintain regulatory files/database

Job Summary As a Sr. Consultant specializing in Devices you will play a pivotal role in driving innovative solutions and strategies for our clients. With a hybrid work model and day shifts you will collaborate with cross-functional teams to enhance device-related processes and outcomes. Your expertise will contribute to the companys mission of delivering cutting-edge technology solutions that positively impact society. Responsibilities Lead the development and implementation of device strategies to optimize client outcomes and enhance operational efficiency. Oversee the analysis of device-related data to identify trends and opportunities for improvement. Provide expert guidance on device selection integration and lifecycle management to ensure alignment with client objectives. Collaborate with cross-functional teams to design and execute device-related projects that meet client needs and expectations. Develop and maintain strong relationships with clients to understand their device requirements and provide tailored solutions. Ensure compliance with industry standards and regulations in all device-related activities. Drive continuous improvement initiatives to enhance device performance and reliability. Conduct training sessions and workshops to educate clients and internal teams on device best practices. Monitor and report on the progress of device projects ensuring timely delivery and quality outcomes. Support the development of proposals and presentations for potential device-related projects. Evaluate emerging device technologies and trends to identify opportunities for innovation. Facilitate knowledge sharing and collaboration among team members to foster a culture of learning and growth. Utilize your domain expertise to contribute to the companys strategic goals and enhance its reputation in the device sector. Qualifications Possess a minimum of 8 years of experience in the devices domain demonstrating a strong track record of success. Exhibit excellent analytical skills to interpret complex device data and derive actionable insights. Demonstrate proficiency in device lifecycle management and integration strategies. Have a solid understanding of industry standards and regulatory requirements related to devices. Show exceptional communication skills to effectively convey technical information to diverse audiences. Display strong problem-solving abilities to address device-related challenges and implement effective solutions.

Role & responsibilities * Data Entry and Updation in Regulatory Information Management System. * Dossier preparation (New/ Renewal/ Variations) for different countries. * Other RA Related Activities. Perks and benefits * 5 days working Environment * Additional Benefits.

To ensure that products with all regulations and legislation, both National and international,throughout the product lifecycleThe RAP works closely with R&D manufacturing QA/QC and mkt to ensure timely registration,compliance and approval of products

Do you want to contribute to the future of healthcareAs Siemens Healthineers values those who dedicate their energy and passion to this cause, our company’s name is dedicated to our employees. It’s their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer. We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone to grow both personally and professionally. Sound interesting Then come in and join India team as Regulatory Affairs Specialist. Your tasks and responsibilities: Planning and preparing product related medical device submissions for the products manufactured at the Bangalore factory according to country specific regulatory requirements and maintaining of licensed products (e.g., for USA, EU, India, Latin America, Asia) Take responsibility for product / component registrations following respective standards such as BIS, AERB, CDSCO for the products used at the Bangalore factory You will provide professional advice to and actively support internal departments, such as product development in implementation and fulfillment of the applicable regulatory requirements (laws, guidelines, regulations) to ensure the registration of the products manufactured. Supporting the audits from the respective authorities of the different countries as a part of the product registration process Your qualifications and experience: You have a diploma or degree in engineering, or a comparable field of study with relevant knowledge of imaging procedures (e.g., radiography, fluoroscopy) and clinical interventional procedures You have 4-5 yrs of experience in medical device registration. You have knowledge of the pertinent regulatory frameworks of the EU, China, India, and Latin America. Experience regarding USA registrations would be beneficial You have professional experience in the regulatory affairs functions or in comparable positions in the medical device industry, and you are very familiar with relevant interfacing processes, such as product risk management, post-market surveillance, and product lifecycle management Your attributes and skills: You show a collaborative, inspiring working style, and you can accommodate different personalities in a functional team You have excellent written and spoken English communication skills You are a great communicator, collaborative, inspiring, and able to accommodate different personalities in a functional team You are experienced in working in a demanding environment, and you pursue the aligned strategic targets by prioritization, consolidation, and smart decision making We win togetheryou are a team player; you follow the Siemens Healthineers goals with dedication and passion for the job Our global team: We are a team of 68,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our job’s alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU and/or UK. Experience with AUS-NZ submissions would be an added advantage. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU and/or UK. Review of documents related to compilation of dossiers, variations and query responses. Up to date knowledge of EU regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge with respect to solid oral dosage forms. Adept at review of manufacturing and analytical documentation from a regulatory perspective. Strong knowledge of CTD /eCTD requirements and hands-on experience with compilation of CTD modules 1 to 5 is mandatory. Hands on experience with portal submissions would be preferable. Ability to try new approaches when faced with challenges. Should have good analytical and learning attitude. Good communication (written and oral) and inter-personal skills.

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Experience Required: CDSCO , USFDA, EUGMP, NAFDAC Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

Responsible for overseeing al aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leading the preparation and submission of regulatory dossiers to health authorities for new drug applications, variations, renewals, and post-market surveillance reports. Ensuring adherence to all applicable regulatory requirements, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and labelling regulations. Building and maintaining strong relationships with regulatory agencies, proactively addressing any concerns or queries regarding product submissions. Managing and developing a team of regulatory professionals, including regulatory affairs managers, specialists, and associates, ensuring their expertise is utilized effectively. Education: B Pharm/M Pharm with exposure in Regulatory Affairs for 15 to 20 years in pharma. Desirable Skills & Competencies: Deep understanding of global pharmaceutical regulations, including ICH guidelines and relevant regional regulations. Extensive experience in the drug development process, from pre-clinical to post-market surveillance. Proven leadership skills in managing and motivating a regulatory affairs team. Excellent communication, negotiation, and interpersonal skills to effectively interact with regulatory agencies and internal Stakeholders. Interested candidates can mail their updated resume & CTC on sumit.s@titanpharma.com. Thanks & Regards, Sumit Shirke HR Department Titan Laboratories Pvt Ltd

Planning, review & submission of CTD/ACTD/eCTD for export market (Markets will work for Europe / US). Registration/Re-registration/post approval changes application for export market. Resolve the technical query related to product registration/Re-registration/post approval changes. Follow-up and coordination with internal stakeholders. Review of technical documents. Review of artwork and pack insert. Preparation and submission of Product safety update report.

Medical Device Safety Physician – MBBS/MD mandatory. Review medical device safety reports (ICSR, SUSAR), assess risks, and ensure MDR/EU/US compliance. PV, clinical trials experience required. Required Candidate profile Strong decision-making, regulatory knowledge. WFO (Mumbai/Gandhinagar/Chennai/Pune/Indore). Salary up to 16 LPA.