Senior Regulatory Executive

1 week ago

Gandhinagar, Gujarat, India Jain Lifecare Pvt Ltd Full time ₹ 3,60,000 - ₹ 4,60,000 per year

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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