
Office Regulatory Affairs
2 days ago
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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