4 - 9 years
6 - 15 Lacs
Posted:1 month ago|
Platform:
Remote
Full Time
Title: Regulatory Affairs-CMC (Junior-Senior level) Location: 100% REMOTE Experience: 4-14 Years Industry: Pharmaceuticals / Life Sciences Job Overview Join our team as a Regulatory Affairs Specialist with 4-14 years of experience in pharmaceuticals or life sciences. We seek a detail-oriented professional skilled in CMC Module 3 preparation and eCTD dossier compilation to ensure compliance with global and Asia market regulatory standards. Key Responsibilities eCTD Dossier Compilation : Draft, Review and compile CTD/eCTD modules, ensuring accuracy, consistency, and alignment of Modules 2.5, 2.7, 3 and 5 with biosimilar justifications. Conduct gap analyses and coordinate corrections. Regulatory Compliance : Support health authority query responses, internal audits, and inspections, ensuring adherence to SOPs and APAC regulations. Collaboration & Training : Act as the regulatory lead for biosimilar projects, train teams on APAC eCTD requirements, and align with CMC, Clinical, and Quality teams for data integrity. Required Qualifications 4-14 years in regulatory affairs (pharma/life sciences). Experience in reviewing documentation related to biosimilars submissions across Asia markets Expertise in CMC Module 3 , eCTD compilation , and APAC regulations (PMDA, NMPA, DCGI). Bachelors/Masters in Pharmacy or Life Sciences. Strong attention to detail and ability to meet deadlines.
Vueverse Consulting Services (opc)
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