We are seeking an experienced Regulatory Affairs professional with expertise in end-to-end (Pre & Post Approval) regulatory activities for the US market to support product registrations, lifecycle management, and regulatory compliance.

Role & responsibilities

Pre-Approval Activities

- Prepare, review, compile, and submit US Drug Master Files (US DMFs) in CTD/eCTD format.
- Author and review Module 2.3 (Quality Overall Summary) and Module 3 sections for API regulatory submissions.

- Prepare regulatory documentation for

- Current DMF submissions

- DMF amendments

- Annual Reports

- Letters of Authorization (LOA)
- Coordinate with R&D;, Analytical Development, Quality Assurance, Manufacturing, and Regulatory CMC teams for dossier preparation.
- Ensure regulatory documentation complies with USFDA, ICH, and FDA Guidance Documents.
- Review manufacturing processes, specifications, analytical methods, validation reports, stability data, and impurity profiles for regulatory submissions.
- Evaluate regulatory impact of process changes before submission.




- Participate in product development meetings to ensure regulatory compliance from the development stage.
- Support customer queries related to regulatory documentation.

Post-Approval Activities

- Manage lifecycle maintenance of US DMFs.

- Prepare and submit

- Annual Reports

- Amendments

- Deficiency Responses

- Information Requests

- Administrative Updates
- Evaluate manufacturing, analytical, and process changes for regulatory impact.

- Prepare and submit
- CBE-0
- CBE-30

- Prior Approval Supplements (PAS)

- Minor and Major Changes
- Handle deficiency letters, FDA information requests, and customer regulatory queries.
- Maintain regulatory commitments and submission timelines.
- Track submission status and ensure timely regulatory compliance.
- Coordinate product lifecycle management activities.

Regards, Dhivakar D [email protected]

📌 Senior Manager - Regulatory Affairs (API) (Chennai)
🏢 BVR People Consulting
📍 Chennai