
Senior Regulatory Affairs Specialist
5 days ago
Job Title:
Sr. Regulatory Executive
Location:
Vadsar, Gandhinagar
CTC:
₹4.0 LPA – ₹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 Middle East, GCC, 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.
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