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
- 1012 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
