Senior Regulatory Executive

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: ₹360,000.00 - ₹460,000.00 per year

Benefits:

• Leave encashment