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

  .