Glenmark Hiring Pharmacy Graduates | Plant Regulatory Affairs Role – Apply Now
Looking for a Regulatory Affairs Job in the pharmaceutical industry? Glenmark Careers is hiring an Officer – Plant Regulatory Affairs for its Pithampur Plant in Indore. B Pharm and M Pharm candidates with knowledge of global regulatory guidelines, pharmaceutical documentation, and compliance can explore this opportunity.
- Job Position: Officer – Plant Regulatory Affairs
- Location: Pithampur Plant, Indore
About The Company
Glenmark Pharmaceuticals is a global pharmaceutical company that operates in the healthcare sector, focusing on developing innovative medicines and providing high-quality healthcare solutions. With a commitment to research and development, Glenmark aims to enhance the quality of life for patients worldwide. The company is headquartered in India and is recognized for its dedication to compliance with international regulatory standards, making it an ideal workplace for those seeking a regulatory affairs job.
Job Description
The Regulatory Affairs Job at Glenmark Careers acts as a key link between the manufacturing plant and the Corporate Regulatory team. The Officer – Plant Regulatory Affairs will support product registrations, regulatory submissions, post-approval changes, dossier documentation, audits, and compliance with ICH, USFDA, EMA, GMP, and other applicable requirements.
Key Responsibilities
- Review documents required for dossiers for new product registrations, license renewals, and variations for the US, Europe, Canada, Australia, and ROW markets.
- Ensure timely availability of documentation and data for corporate regulatory submissions, post-approval changes, and deficiency responses.
- Review change controls, incidents, and deviations from a regulatory perspective, providing recommendations for data generation.
- Compile and submit projected annual reports for the US market
- Ensure compliance with GMP, GCP, ICH, USFDA, EMA, and site SOPs.
- Coordinate with various internal departments (R&D, QA, QC, Production, Purchase, etc.) to gather necessary documents and samples for regulatory submissions.
- Stay current with evolving national and international legislation and guidelines, providing strategic advice to management on regulatory matters.
- Assist the Quality team in preparing and managing audits and inspections by national and international regulatory bodies.
Eligibility Criteria
- Education: B Pharm / M Pharm, life sciences, chemistry, or a related field.
- Experience: Relevant pharmaceutical Regulatory Affairs experience, particularly in plant regulatory activities, dossier documentation, submissions, and compliance, would be suitable for the role.
Required Skills
- Technical Skills: In-depth knowledge of global regulatory guidelines (e.g., ICH, USFDA, EMA).
- Soft Skills: Strong analytical abilities, meticulous attention to detail, excellent written and oral communication skills, project management capabilities, and strong negotiation skills.
- Systems & Tools: Proficiency in SAP system, Trackwise, MSB & OpenText for QMS approvals. Skilled in MS Office for preparation of regulatory documents.
Why Join Glenmark?
This Regulatory Affairs Job at Glenmark Careers provides an opportunity to gain exposure to global regulatory markets and work closely with manufacturing, Quality, R&D, and corporate regulatory teams. The position can help professionals strengthen their expertise in dossier management, regulatory compliance, audits, and international pharmaceutical regulations.
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