
Senior Regulatory Executive
4 days ago
Job Title: Sr. Regulatory Executive
Location: Vadsar, Gandhinagar
CTC: ₹3.6 LPA – ₹4.6 LPA
Experience Required: 2–4 years in Regulatory Affairs (Pharma or Cosmetics)
Educational Qualification: B.Pharm / M.Pharm – Drug Regulatory Affairs, Quality Assurance, Pharmacology, or Pharmaceutical Analysis
Roles & Responsibilities:
- Prepare and review dossiers in accordance with regulatory guidelines (EU, GCC, USFDA, and other markets).
- Review, verify, and approve artworks, labels, and packaging components to ensure compliance with regulations.
- Prepare and maintain regulatory documents, technical files, and submissions for product approvals and renewals.
- Coordinate with internal departments (R&D, QA, QC, Production) to gather data required for submissions.
- Maintain and update records of licenses, registrations, and regulatory approvals.
- Monitor and interpret changes in regulatory guidelines and ensure compliance.
- Support in regulatory audits, inspections, and provide necessary documentation.
- Assist in preparing product information files (PIF) and safety data as per regulatory requirements.
- Ensure timely submissions and follow-ups with authorities or consultants for approvals.
Qualifications & Skills Required:
- 2–4 years of proven experience in Regulatory Affairs (Pharma or Cosmetics).
- Strong knowledge of regulatory guidelines across EU, GCC, USFDA, and other international markets.
- Proficiency in dossier compilation, artwork review, and document control.
- Familiarity with regulatory software/tools and e-submissions.
- Excellent communication and documentation skills.
- Strong attention to detail, problem-solving ability, and ability to work cross-functionally.
Job Types: Full-time, Permanent
Pay: ₹360, ₹460,000.00 per year
Benefits:
- Leave encashment
Work Location: In person
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