Glenmark Hiring Pharma Graduates for Regulatory Affairs Role – Apply Now
A rare chance has emerged for aspiring professionals in the pharmaceutical sector. Glenmark Pharmaceuticals is offering a regulatory affairs job as an Officer in their Pithampur Plant, Indore. This role is pivotal in ensuring compliance with international regulations, making it an excellent opportunity for candidates with a background in life sciences.
- Position: Officer – Plant Regulatory Affairs
- Location: Pithampur Plant, Indore
About The Company
Glenmark Pharmaceuticals is a leading global pharmaceutical company based in India, specializing in the development of innovative medicines. The organization operates in various therapeutic areas and is committed to enhancing the quality of life through its products. With a strong emphasis on research and development, Glenmark is well-positioned in the pharmaceutical industry, making it an attractive choice for professionals seeking a regulatory affairs job.
Job Description
The Officer, Plant Regulatory Affairs, at Glenmark will serve as a crucial link between the manufacturing plant and the corporate regulatory team. This role involves ensuring that all products, processes, and documentation comply with international regulations, including ICH, USFDA, and EMA guidelines. The successful candidate will be responsible for managing regulatory submissions and maintaining compliance across various markets.
Key Responsibilities
- Review regulatory documents required for global dossier submissions.
- Support new product registrations, license renewals, and post-approval variations.
- Review change controls, deviations, and incidents from a regulatory perspective.
- Prepare and submit annual reports for the US market.
- Review batch manufacturing records, process validation reports, stability data, and technical documents.
- Coordinate with R&D, QA, QC, Production, and Purchase teams for regulatory documentation.
- Support responses to regulatory deficiencies and queries.
- Assist during regulatory audits and inspections.
- Ensure compliance with GMP, GCP, Site SOPs, ICH, USFDA, and EMA guidelines.
- Stay updated with changing global regulator
Eligibility Criteria
Education: B.Pharm / M.Pharm, life sciences, chemistry, or a related field.
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 is an excellent opportunity for pharmacy and life sciences professionals who want to build a career in global pharmaceutical regulatory affairs. Candidates with strong knowledge of international regulatory guidelines and manufacturing compliance are encouraged to apply.
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