Manager - Regulatory Affairs

We are seeking a highly experienced and meticulous Manager - Regulatory Affairs to oversee and execute all regulatory activities for drug substances and products. The ideal candidate will be responsible for the preparation, submission, and management of various regulatory documents, ensuring compliance with global regulatory agencies. This role requires strong coordination skills, attention to detail, and a proactive approach to addressing regulatory requirements and challenges.

Responsibilities :

• Oversee the preparation and review of Drug Master Files (DMF) / Common Technical Documents (CTD) for various drug substances.
• Manage the preparation and submission of Technical Packages / Product Dossiers to regulatory authorities.
• Prepare essential regulatory correspondence, including Declaration of Access, Letter of Access, Letter of Commitment, Letter of Engagement, and Submission Letters .
• Effectively handle deficiencies received from regulatory agencies and customers , ensuring timely and comprehensive responses.
• Lead the preparation and submission of Quality Questionnaires and related documents received from customers.
• Ensure strong coordination with internal departments such as QC, QA, Stores, Production, and R&D with respect to all regulatory requirements.
• Provide comprehensive marketing support from a regulatory perspective.
• Manage the preparation and submission of documents for Drug Licenses, Written Confirmations, NOC (No Objection Certificates), FSSAI Licenses, Free Sale Certificates, and GMP (Good Manufacturing Practice) Certificates .
• Undertake any other activity assigned by the department head related to regulatory affairs.
• Drive the improvement, periodic review, and updation of current SOPs (Standard Operating Procedures) and work systems to ensure compliance and efficiency.
• Ensure that sourcing material, manufacturing, and testing processes are carried out as per the dossier accepted for registration by the concerned regulatory agency.
• Oversee the preparation of all documents required for regulatory affairs submissions .
• Monitor Qualification of new / modified areas / equipment and ensure their periodic requalification.
• Conduct thorough reviewing of technical agreements and Quality agreements .

Skills Required

Manufacturing, Documentation, CTDs, Coordination Skills