Office Regulatory Affairs

3 weeks ago

Mumbai, India Kremoint Pharma Full time

Job Title / Designation
Office Regulatory Affairs

Organization Name
Kremoint Pharma Pvt. Ltd.

Job Location
Vikhroli

Job Description / Responsibilities

  • Prepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market.
  • Apply for Free Sale Certificate (FSC) and Product Permission (PP) on FDA portal.
  • Review and check artworks as per country-specific regulations.
  • Coordinate with F&D, QA/QC, Production, Packaging, and Design teams to collect documents such as Product Code, PDR, MFR, BMR/BPR, PVP/PVR, Specifications, COA, Stability Data, AMV, and Artworks required for submissions.
  • Maintain accurate records of registration samples and regulatory documents.
  • Support compliance with international regulatory standards and ensure timely submissions.

Desired Candidate Profile

  • Must be from Pharma background.
  • Qualification: B.Pharm / M.Pharm / B.Sc (Chemistry) / M.Sc / Regulatory Affairs course.
  • Experience: 2 - 4 years in Regulatory Affairs.
  • Skills: Strong documentation, coordination, and MS Office skills.
  • Attributes: Detail-oriented, proactive, and strong learning attitude.

Compensation

  • Salary: As per candidate profile and experience.

Contact Details

Email ID:
Phone: / /

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