Regulatory Affairs Specialist

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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 SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to lead our global regulatory strategy and ensure compliance with regulatory guidelines.This is an exciting opportunity for an experienced professional to take ownership of CMC regulatory submissions, ensuring timely delivery and adherence to regulatory requirements....

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,...

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...

We are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profileB.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...

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...

Regulatory Affairs CMCExperience: 6-11 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, US market, CMC

Regulatory Affairs AssociateExperience: 3-6 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, EU market, Formulation, RA, European market, Post and Pre approval

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...