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Regulatory Affairs ExecutiveIntas Pharmaceuticals · Ahmedabad, Gujarat, India
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Intas Pharmaceuticals

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Regulatory Affairs Executive

🗓️ Posted 2026-09-08 Ahmedabad, Gujarat, India Full-time Hybrid Healthcare Medical
💰 Salary ₹25,000–₹50,000/mo (₹300,000–₹600,000/yr) 📊 Market ₹25,000–₹45,000/mo

About the Company

Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems.

Responsibilities

  • ● Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations.
  • ● Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner.
  • ● Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulations.
  • ● Develop and submit variation packages for ongoing lifecycle management of approved products.
  • ● Monitor and interpret changes in regulatory guidelines and approval processes worldwide.
  • ● Conduct regulatory impact assessments for product or process changes.
  • ● Support regulatory audits conducted by customers and Ministry of Health (MOH).
  • ● Perform gap analysis and review clinical and CMC documentation to support regulatory submissions.

Requirements

  • ● Strong knowledge of global regulatory requirements and submission formats (FDA, EMA, ICH guidelines).
  • ● Hands-on experience with preparation of IND, IMPD, CTD dossiers and regulatory documentation.
  • ● Detail-oriented with excellent document management skills.
  • ● Effective communication and coordination with cross-functional teams.
  • ● Analytical skills to assess regulatory impacts and address compliance issues.
  • ● Ability to work independently and manage multiple regulatory activities simultaneously.
  • ● Master's Degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.
  • ● 2 to 4 years of experience in regulatory affairs, ideally with exposure to recombinant or biologic products.