Job Summary
We are looking for a Regulatory Affairs Executive for our pharmaceutical company. The candidate should have strong knowledge of pharmaceutical regulations and dossier preparation. Experience in handling regulatory submissions for international markets, especially Vietnam dossier preparation, is mandatory.
Key Responsibilities
- Preparation, review, and submission of regulatory dossiers for pharmaceutical products.
- Mandatory handling of Vietnam regulatory dossiers and compliance requirements.
- Coordination with internal departments such as R&D, QA, QC, Production, and Marketing for document collection and submission.
- Compilation of ACTD/CTD dossiers for product registration and renewals.
- Managing product registration, variation filings, renewals, and query responses.
- Reviewing product labels, packaging materials, and artworks as per regulatory guidelines.
- Monitoring changes in regulatory requirements across target markets.
- Maintaining regulatory documentation and records.
- Liaising with health authorities, agents, and international partners for regulatory approvals.
- Ensuring compliance with local and international pharmaceutical regulations.
Required Skills
- Strong knowledge of pharmaceutical regulatory requirements.
- Hands-on experience in Vietnam dossier preparation is mandatory.
- Knowledge of ACTD/CTD dossier compilation.
- Good understanding of product registration processes for export markets.
- Strong documentation and communication skills.
- Ability to work independently and manage multiple projects.
Educational Qualification
Preferred Candidate Profile
- Experience in regulated markets and export documentation.
- Good coordination and follow-up skills.
- Attention to detail and compliance-focused mindset.
Pay: ₹25,000.00 - ₹45,000.00 per month
Work Location: In person
