Cadila Pharmaceuticals Limited
Are you an experienced professional in Regulatory Affairs looking for a rewarding career in the US Market segment?
Cadila Pharmaceuticals Limited is hiring for the role of Executive/Sr. Executive – Regulatory Affairs at its Dholka location. If you have 4-5 years of experience and expertise in dossier submission, post-approval activities, and regulatory compliance, this opportunity is for you!
Job Details
- Position: Executive/ Sr. Executive – Regulatory Affairs
- Department: Regulatory Affairs – US Market
- Location: Dholka
- Experience Required: 4-5 Years
Key Responsibilities
- Regulatory Submissions: Compilation, review, and submission of registration dossiers for the US region.
- Regulatory Queries: Handling queries and deficiencies from regulatory agencies.
- Post-Approval Activities:
- Reviewing Annual Reports and post-approval supplements (CBE-0, CBE-30, PAS).
- Managing eCTD software for ANDA submissions, query responses, and post-approval filings.
- Technical Document Review:
- Approving specifications, test procedures, product development reports, and stability protocols.
- Reviewing analytical method validation, verification, and transfer reports.
- Compliance & Documentation:
- Reviewing DMFs and their notifications.
- Approving Change Controls and Deviations.
- Maintaining the Regulatory Database for all submissions.
- Regulatory Tracking & Training:
- Keeping up with regulatory guidance documents and ensuring compliance.
- Conducting training sessions on new regulatory guidelines.
- Additional Assignments: Any other tasks assigned by the reporting authority.
Why Join Cadila Pharmaceuticals?
Cadila Pharmaceuticals is a globally recognized pharmaceutical company, known for its innovation and commitment to quality. This role provides an excellent opportunity to work in a dynamic regulatory environment, gain exposure to international markets, and contribute to global drug development and compliance.
How to Apply?
📩 Interested candidates can share their CVs at:
✉️ [email protected]
