Key Responsibilities
1. Regulatory Filings & Submissions
- Prepare and review regulatory documents: DMF, ASMF, CEP, CTD, eCTD for USFDA, EMA, TGA, Health Canada, Japan PMDA
- Handle responses to regulatory queries and deficiency letters
- Track and manage filing timelines for new products and line extensions
2. Compliance & Audit Management
- Ensure compliance with cGMP, ICH guidelines, and regulatory requirements
- Act as RA representative during USFDA, EU, WHO, and customer audits
- Implement CAPA and ensure closure of audit observations
3. Product & Site Approvals
- Coordinate with R&D, QA, QC, and Production for product development and technology transfer
- Support site approvals, variation filings, and post-approval changes
- Maintain regulatory database and track product registrations globally
4. Strategy & Business Support
- Provide regulatory guidance for new product launches and market entry strategy
- Liaise with regulatory agencies, consultants, and agents in different countries
- Monitor regulatory updates and assess impact on existing product
5. Team Leadership
- Lead and mentor a team of RA executives
- Train cross-functional teams on regulatory requirements
- Drive continuous improvement in RA processes
Required Skills
- Knowledge- Strong knowledge of USFDA, EU, ICH, cGMP guidelines. Hands-on experience in DMF/ASMF/CEP filings
- Skills- Excellent documentation, communication, negotiation, and audit handling skills
- Other: Experience in handling USFDA/EU audits is mandatory. Must be able to travel for audits and meetings
Preferred
- Experience with regulated market filings
- Knowledge of eCTD publishing tools
- Existing liaison with USFDA/EMA
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