AI-Driven Regulatory Affairs Specialist

We're seeking a highly skilled Regulatory Affairs Specialist to join our team. This role combines domain expertise with product leadership, making you the bridge between industry workflows and cutting-edge AI solutions.Key Responsibilities:Provide subject matter expertise in Life Sciences/Pharma/Biotech/MedTech processes, regulations, and workflowsDevelop...

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...

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...

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...

Job Title:Regulatory Affairs SpecialistWe are seeking an experienced Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals in Europe.This role is pivotal in managing activities pertaining to new application submissions for Europe through DCP, MRP, NP.Key...

Regulatory Affairs Expert for Pharma and Life SciencesWe are seeking a highly skilled Regulatory Affairs expert to join our team. This individual will play a critical role in ensuring compliance with regulatory requirements in the pharmaceuticals and life sciences sector.Strong expertise in Life Sciences / Pharma / BioTech / MedTech processes, regulations,...

We are an AI-native startup building AI for regulatory compliance in the pharmaceuticals and life sciences sector. We're looking for a deep subject matter expert in regulatory affairs for Pharma / Life Sciences to join our core team. This role combines domain expertise with product leadership, making you the bridge between industry workflows and cutting-edge...

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...