Job Summary:

Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems.

Key Responsibilities:

- Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations.
- Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner.
- Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulations.
- Develop and submit variation packages for ongoing lifecycle management of approved products.
- Monitor and interpret changes in regulatory guidelines and approval processes worldwide.
- Conduct regulatory impact assessments for product or process changes.
- Support regulatory audits conducted by customers and Ministry of Health (MOH).




- Perform gap analysis and review clinical and CMC documentation to support regulatory submissions.

Skills & Competencies:

- Solid knowledge of global regulatory requirements and submission formats (FDA, EMA, ICH guidelines).
- Hands-on experience with preparation of IND, IMPD, CTD dossiers and regulatory documentation.
- Detail-oriented with excellent document management skills.
- Effective communication and coordination with cross-functional teams.
- Analytical skills to assess regulatory impacts and address compliance issues.
- Ability to work independently and manage multiple regulatory activities simultaneously.

Proficiency with regulatory submission tools and tracking systems. Education Qualification: Master’s Degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.

Experience:

- 2 to 4 years of experience in regulatory affairs, ideally with exposure to recombinant or biologic products.

📌 Regulatory Affairs Executive (Ahmedabad)
🏢 Intas Pharmaceuticals
📍 Ahmedabad