Greetings!!!
We are seeking an experienced Regulatory Affairs (API) 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.
Intrested candidates kindly share your updated CV to
[email protected]
📌 Regulatory Affairs - API Leading Pharma - Chennai
🏢 BVR People Consulting
📍 Chennai