Global Regulatory Affairs Specialist

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 1925 GlaxoSmithKline LLC.About the RoleAs a Regulatory Affairs Specialist, you will be responsible for ensuring the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital...

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Genpact. As a Lead Regulatory Affairs Expert, you will play a critical role in ensuring compliance with labeling regulations and guidelines.Key ResponsibilitiesLiaise with key interfaces to ensure project requirements are met and timelines are mutually...

Business: Piramal Critical Care Department: Regulatory AffairsLocation: Kurla, MumbaiTravel: LowJob OverviewAs a Regulatory Affairs Specialist, you will be responsible for managing Regulatory Filings for Europe with minimal supervision.Key Stakeholders: InternalCountry manager, Plant, QA, Artwork department, Supply Chain, PVKey Stakeholders: ExternalHealth...

Job Title: Regulatory Affairs SpecialistKey Responsibilities:Ensure compliance with regulatory requirements for API Plant operations.Manage DMF compilation and lifecycle management.Coordinate change control and related submissions.Develop and maintain quality standards.Requirements:Qualifications:Minimum 2 years of experience in regulatory affairs or quality...

Regulatory Affairs Role OverviewCounselect Services Private Limited is seeking a skilled Regulatory Affairs Specialist to join their team. This role involves handling the regulatory function for drugs, cosmetics, and food products in both domestic and international markets.The ideal candidate will have knowledge of regulations such as the Drugs and Cosmetics...

**Job Overview:**The Regulatory Affairs Specialist will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, and collaborating with others in the organization to contribute to the success of the business.**Key Responsibilities:**Prepare Red Books for key...

Piramal Pharma Solutions Department: Corporate Regulatory Affairs Job Overview: We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Kurla. The successful candidate will be responsible for the submission of regulatory dossiers for targeted markets, ensuring compliance with CDMO and Agile businesses. Key Stakeholders: Sites –...

Business: Piramal Pharma Solutions Department: Corporate Regulatory Affairs Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our Corporate Regulatory Affairs team at Piramal Pharma Solutions. In this role, you will be responsible for submitting regulatory dossiers for targeted markets as per business needs to support CDMO and Agile...

About Apotex Inc.Apotex Inc. is a Canadian-based global health company producing high-quality, affordable medicines for patients worldwide. With almost 7,200 employees globally, Apotex operates in manufacturing, R&D, and commercial operations.Job SummaryWe are seeking a skilled Regulatory Affairs Specialist to perform labelling update and maintenance...

Job Summary:Sun Pharma Advanced Research Company Ltd. is seeking a highly skilled Regulatory Affairs Specialist to support the development and execution of regulatory strategies for our pharmaceutical products. The ideal candidate will have a strong background in CMC regulatory affairs and excellent communication skills.Key Responsibilities:Authoring CMC...

About the RoleWe are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel.As a Regulatory Affairs Consultant, you will be responsible for handling the life cycle management of approved drug products, including tablets, syrups, and parenterals.You will lead and contribute to the planning, preparation, and delivery of regulatory...

About ApotexApotex is a global health company that produces high-quality, affordable medicines. The company employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in over 75 countries. Through vertical integration, the Apotex group focuses on developing and selling generic,...

Job DescriptionAs a Regulatory Affairs Manager at 1925 GlaxoSmithKline LLC, you will be responsible for leading global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures, and...

We are seeking a highly skilled Regulatory Affairs Specialist to join our Quality team at 1054 GlaxoSmithKline Services Unlimited.The successful candidate will be responsible for ensuring compliance with global, regional and national regulatory requirements and GMP guidelines, including risk management. Key responsibilities include:Managing operations to...

IF MedTech Pvt Ltd is revolutionizing healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives.We are seeking a skilled Regulatory Affairs Specialist...

Job SummaryThis role is responsible for handling and maintaining product compliance throughout the entire product life-cycle, encompassing various product categories. The successful candidate will report to the Team Lead, Regulatory Operations.Responsibilities:Support the Regional Regulatory Affairs Department in new product registration and life-cycle...

Job Overview: We are seeking a highly skilled Medical and Regulatory Affairs Specialist to join our team at Piramal Group. The successful candidate will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, and providing scientific training for marketing...

About Apotex Inc.Apotex Inc. is a global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs almost 7,200 people in manufacturing, R&D, and commercial operations. Our focus is on developing and selling generic, biosimilar, and specialty products through vertical...

Job Title: Regulatory Affairs ExecutiveIpca Laboratories Limited is seeking a highly skilled Regulatory Affairs Executive to join our team.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with US FDA guidelines.Prepare and submit registration dossiers, renewal applications, and variations as per regulatory...

Business: Piramal Pharma SolutionsDepartment: Corporate Regulatory AffairsLocation: GlobalTravel: LowJob OverviewSubmission of regulatory dossiers for targeted markets as per business needs to support CDMO and Agile businesses.Key Stakeholders: InternalSites – Pithampur, Lexington, Morpeth, PPDS-Ahmedabad, Mumbai R&D, Digwal, Supply Chain, Finance, Shared...