Manager - Regulatory affairs (EU/SEA Market)

Key Responsibilities

• Prepare, review, and submit product registration and renewal dossiers (CTD/ACTD) for Europe and Southeast Asia markets
• Understand, interpret, and implement regulatory guidelines applicable to different European Union and Southeast Asia countries
• Prepare and renew registrations, manufacturing licenses, product approvals, WHO-GMP certificates, CPP/COPP, FSC, MSO registrations, and other regulatory documentation required by health authorities
• Lead the preparation, review, and submission of regulatory dossiers and documents to relevant authorities across Europe and Southeast Asia
• Respond to queries, variations, clarifications, and provide additional information to regulatory authorities within defined timelines
• Obtain market-specific approvals such as product registrations, test licenses, site/plant approvals, FSC, CPP/COPP, and other regulatory clearances
• Review and approve product artworks to ensure compliance with regulatory requirements, country-specific labeling norms, and pharmacopoeial standards
• Ensure ongoing regulatory compliance as per EU and Southeast Asia guidelines and maintain up-to-date knowledge of evolving regulatory requirements

Preferred Candidate Profile

• B.Pharm / M.Pharm graduate
• 10–12 years of experience in Regulatory Affairs for pharmaceutical formulations, specifically handling Europe and Southeast Asia markets
• Strong experience in preparation, review, and lifecycle management (renewals, variations, amendments) of CTD/ACTD dossiers
• Experience in preparing and submitting applications to European and Southeast Asia regulatory authorities and coordinating with local agents, distributors, or partners
• Strong knowledge of regulatory compliance, labeling requirements, and pharmacopoeial standards for Europe and Southeast Asia
• Ability to stay updated on evolving regulatory requirements and ensure ongoing compliance