Regulatory Officer

1. Regulatory Submissions & Approvals:

• Prepare, review, and submit

  drug regulatory dossiers

  (e.g., Formulations, APIs, supplements) to

  CDSCO, state FDA, and other authorities

  .
• Follow up on

  approval status, queries, and responses

  with regulatory bodies.
• Maintain

  trackers of pending applications, renewal dates, and approvals

  .

2. Documentation & Compliance:

• Ensure preparation of

  regulatory documents, SOPs, product labeling, packaging inserts, and promotional materials

  in compliance with regulatory norms.
• Maintain accurate records of

  regulatory correspondence, approvals, and submissions

  .
• Support internal audits and inspections with regulatory documentation.
  

3. Product Lifecycle Management:

• Monitor and implement

  regulatory requirements

  for new product development, modifications, and withdrawals.
• Coordinate with

  R&D, QC, Production, and Marketing

  teams for timely compliance.
• Ensure timely

  renewal of licenses, registrations, and certificates

  for products.

4. Labeling & Packaging Compliance:

• Review and approve

  product labels, cartons, and inserts

  according to regulatory guidelines.
• Ensure

  compliance with marketing claims, mandatory statements, and safety warnings

  .

5. Regulatory Intelligence & Support:

• Stay updated on

  changes in national and international regulatory guidelines

  .
• Provide guidance to internal teams regarding

  compliance, regulatory strategy, and submission requirements

  .
• Assist in

  training staff

  on regulatory policies and updates.

6. Coordination & Communication:

• Liaise with

  regulatory authorities, consultants, and industry bodies

  .
• Collaborate with

  QA, Production, QC, and Marketing

  departments to ensure regulatory compliance in operations.
• Support audits, inspections, and any regulatory queries from authorities or customers.
  

Qualifications & Experience:

• Education:

  B.Pharm / M.Pharm / Life Sciences / Biotechnology / Chemistry.

• Experience:

  25 years of experience in

  Regulatory Affairs in pharmaceutical formulation or API industry

  .

• Technical Skills:

• Knowledge of

  CDSCO regulations, Drug & Cosmetic Act, GMP, and regulatory guidelines

  .
• Understanding of

  registration procedures, dossier preparation, and labeling compliance

  .
• Proficiency in documentation and report preparation.