Regulatory Affairs-CMC (Junior-Senior level) @ Vueverse Consulting

Job Description

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.

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Keyskills:   CMC module 3 eCTD dossier compilation Regulatory Affairs Regulatory Documentation