Location: Vadodara, Gujarat
Industry: Pharmaceuticals
Job Type: Full-time
Job Description
Mepro Pharmaceuticals Pvt. Ltd. (Unit-III), a leading name in the pharmaceutical industry, is seeking experienced professionals for its Regulatory Affairs Department in Vadodara, Gujarat. The company has multiple openings for roles such as Assistant/Deputy Manager, Officer, Sr. Officer, and Executive to oversee regulatory submissions, compliance, and dossier management for injectable and OSD (Oral Solid Dosage) products.
Key Responsibilities:
- Prepare, review, and submit dossiers in CTD/ACTD formats for TGA, Europe, and global markets.
- Ensure compliance with ICH guidelines, handle regulatory queries, and manage product lifecycle activities.
- Coordinate with cross-functional teams for technical documentation, CMC reviews, and method validation.
- Support global tender documentation and site transfer dossiers for OSD products.
About Mepro Pharmaceuticals Pvt. Ltd.
Mepro Pharmaceuticals is a Gujarat-based pharmaceutical company committed to delivering high-quality healthcare solutions. With a strong focus on regulatory compliance and innovation, Mepro specializes in injectable and OSD formulations, serving both domestic and international markets. The company fosters a collaborative work environment and encourages professional growth.
Eligibility Criteria
For Assistant/Deputy Manager Roles:
- Qualification: B.Pharma/M.Pharma
- Experience: 10–16 years in regulatory affairs (injectables/OSD).
- Skills: Expertise in CTD/ACTD submissions, ICH guidelines, and global regulatory compliance.
For Officer/Sr. Officer/Executive Roles:
- Qualification: B.Pharma/M.Pharma
- Experience: 1–5 years in regulatory submissions (OSD/injectables).
- Skills: Knowledge of dossier preparation, lifecycle management, and regulatory tracking.
How to Apply
Eligible candidates can email their updated CV to hr3@mepro.in with the subject line:
“RA9062025 – [Your Name] – [Position Applied For]”.
