Regulatory Affairs Specialist – API | Sun Pharma | Gurgaon

Job Description

Regulatory Affairs Specialist with also exp. with API

Roles and Responsibilities:

• To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements.
• To review outsourced intermediates for regulatory adequacy to support Procurement Team in vendor selection.
• Coordinate with Chemical Research Department, Analytical Department, and Manufacturing locations in generating data as per the requirements of regulatory agencies.
• To ensure reposition of API dossiers into a central repository and to provide information about
  regulatory commitments in a timely manner.

Deliverables:

• Compilation of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs and ensuring their updation.
• Preparation of Regulatory Amendments / Variations for smooth API supplies and responses to regulatory deficiencies.
• Regulatory support to Chemical Research Department, Analytical Department, Chemical manufacturing, Quality Assurance, Procurement Team, and Regulatory Affairs-Pharma.
• Ensure reposition of regulatory database and compliance with departmental guidelines.

Qualification: M.Pharma, MS/M.Sc(Science) in Organic Chemistry