Job Description

Area Of Responsibility

• 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.
• To coordinate with Chemical Research Department, Analytical Department Chemical manufacturing and Quality Assurance, in generating data as per the requirements of regulatory agencies.
• Regulatory support to Procurement Team and Regulatory Affairs-Pharma
• Ensure compliance to regulatory & departmental guidelines
• To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in 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 to departmental guidelines.

Skills Required