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 dhivakar@bvrpc.com