SUN PHARMA Exe / Sr Exe - Regulatory Affairs - API

Education: M.Sc. (Organic Chemistry)

Experience: 3 – 6 yrs

Job Description:

• Review all data and documents related to product registrations for various health  authorities

• Compilation of Drug Master Files, Registration Dossiers & Technical Data Packages/OpenParts for In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation.

• Prepare responses to deficiency letters received from various agencies for expeditious approval.

• Preparation of Regulatory Amendments / Variations for smooth API supplies.

• Provide regulatory support to cross functional departments.

• Reposition of regulatory database and compliance to procedures.

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