Regulatory Affairs Specialist - Food / Pharma Industry

About the Role

Manager – Regulatory Affairs

Key Responsibilities

• Develop and implement

  regulatory strategies

  for new and existing products.
• Prepare, review, and file

  dossiers, NDAs, notifications, and submissions

  with regulatory bodies.
• Ensure ongoing compliance with

  GMP, GCP, labeling, and advertising standards

  .
• Maintain and update

  regulatory documentation

  (technical files, safety dossiers, product registrations).
• Liaise with

  regulatory authorities (CDSCO, State FDA, DCGI, port offices)

  for approvals and queries.
• Collaborate cross-functionally with

  R&D, QA, Marketing, and Legal

  teams to ensure compliance throughout the product lifecycle.
• Lead regulatory support for

  audits, inspections, and certifications

  .
• Monitor

  global regulatory updates (FSSAI, FDA, EU, ASEAN, GCC, NAFDAC)

  and assess impact on the business.
• Oversee

  post-market regulatory management

  including change control, reporting, and recalls.

Qualifications

• Bachelor’s / Master’s degree in

  Pharma, Regulatory Affairs, Food Science, Chemistry, or Life Sciences

  .

• 5–10 years’ experience

  in Regulatory Affairs (Pharma, Nutraceuticals, Food, or Healthcare).
• Strong knowledge of

  Indian & international regulations

  (FSSAI, FDA, DSHEA, FSMA, EU).
• Experience in

  product submissions, NDAs, compliance audits, and dossier management

  .
• Excellent

  analytical, communication, and project management

  skills.