Regulatory Affairs Manager

Job DescriptionLet's do this. Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by:Driving continuous improvement of processes and...

Job Title: Regulatory Affairs SpecialistAbout This RoleWe are seeking a detail-oriented professional to support end-to-end submissions for global markets, focusing on regulatory affairs - CMC (Chemical, Manufacturing and Controls) aspects.Key ResponsibilitiesPreparing Variation documentsEvaluating post-approval CMC changes in compliance with global...

Regulatory Affairs Specialist OpportunityWe are seeking a highly skilled Regulatory Affairs professional to support our team in the US market.Key Responsibilities:Prepare and review regulatory submissions, including ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, and PADER in eCTD format.Maintain compliance with US FDA and ICH...

Job Title:Regulatory Affairs Specialist - CMCJob Description:This position involves supporting submissions to regulatory authorities and managing the lifecycle of products. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Prepare, review, and compile high-quality regulatory submissions in electronic format,...

GreetingsWe are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes.Key Responsibilities:Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved...

Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.- Maintain...

Job SummarySeeking a highly skilled Regulatory Affairs Specialist to prepare, review, and maintain regulatory documents ensuring compliance with international guidelines and country-specific requirements.Key ResponsibilitiesScreen and analyze documents received for product registration requests as per country-specific guidelines.Prepare, compile, and review...

Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to support end-to-end submissions for global markets.The ideal candidate will possess expertise in Lifecycle Management, Veeva Vault RIM, and complex Initial and Variation submissions.Key ResponsibilitiesPrepare variation documents and/or evaluate post-approval CMC...

This role is for one of the Weekday's clientsSalary range: Rs Rs ie INR LPA)Min Experience: 3 yearsLocation: HyderabadJobType: full-timeWe are seeking a detail-oriented Regulatory Affairs Officer with 2–8 years of experience to join our team in Hyderabad, Nacharam. The ideal candidate will have expertise in Drug Master Files (DMF), ICH guidelines, and...

Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...