Senior Regulatory Affairs Specialist

5 days ago

Ahmedabad, Gujarat, India Jain Soap & Jain Lifecare Pvt Ltd Full time ₹ 32,00,000 - ₹ 48,00,000 per year

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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