Are you a skilled professional in the field of regulatory affairs with a passion for excellence? Cadila Pharmaceuticals is seeking experienced candidates to join our team in Dholka, Gujarat.
Position Overview
- Position: Regulatory Affairs
- Qualification: M.Pharm
- Experience: Minimum 7 years of relevant experience
- Location: Dholka, Gujarat
Key Responsibilities
As a part of our Regulatory Affairs team, you will:
- Compile, review, and submit registration dossiers for the US market.
- Handle regulatory queries and deficiencies effectively.
- Manage post-approval activities, including Annual Reports, post-approval supplements (CBE-0, CBE-30, PAS).
- Utilize eCTD software for ANDA/IND submissions, query responses, and post-approval submissions.
- Review and approve functional documents such as:
- Specifications and test procedures
- Product development reports
- Stability protocols
- Process validation protocols and reports
- Batch manufacturing and packaging records
- Formula clearance
- Evaluate analytical method validation, verification, and transfer reports.
- Review DMF documents and related notifications.
- Approve and monitor change controls and deviations.
- Maintain and update regulatory databases for all submissions.
- Track and stay updated with regulatory guidance documents.
- Conduct training sessions for the team on new regulatory guidelines.
Why Join Cadila Pharmaceuticals?
- Be a part of a leading pharmaceutical company with a rich legacy of innovation.
- Work in a dynamic and supportive environment.
- Contribute to projects that impact global healthcare standards.
- Opportunity to grow your expertise in regulatory affairs.
How to Apply
If you meet the qualifications and are ready for a challenging role, share your updated resume with us at disha.bhalani@cadilapharma.com.
