Regulatory Affairs Manager- API

Role & responsibilities :-

• Review and 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.
• Preparation of responses to regulatory deficiencies received from Agencys and customer.
• 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.
• Ensuring timely Regulatory Notifications to Manufacturing locations