Regulatory Affairs - API Leading Pharma - Chennai

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:

• New 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]