Glenmark Regulatory Affairs Jobs for Chemistry Graduates
Looking for exciting Regulatory Affairs Jobs in the pharmaceutical industry? Glenmark is hiring for the position of Officer – Plant Regulatory Affairs at its Pithampur Plant in Indore. This opportunity is ideal for candidates from Chemistry, Life Science, B.Pharm, and M.Pharm backgrounds who want to build a career in global regulatory compliance, documentation, and pharmaceutical regulations. Explore Glenmark Careers and take the next step toward a rewarding pharma career.
- Position: Officer – Plant Regulatory Affairs
- Location: Pithampur Plant, Indore
- Function: Global Regulatory Affairs
About the Company
Glenmark Pharmaceuticals is a global pharmaceutical organization focused on developing and delivering innovative healthcare solutions across multiple therapeutic areas. The company operates with a strong emphasis on research, manufacturing excellence, quality, and regulatory compliance. Through Glenmark Careers, professionals get opportunities to work in a collaborative environment while contributing to global pharmaceutical operations and advancing their expertise in regulatory and healthcare domains.
Job Description:
The Officer – Plant Regulatory Affairs at Glenmark acts as a vital link between the manufacturing plant and the corporate regulatory team. This position ensures that all products, processes, and documentation comply with international regulations such as ICH, USFDA, and EMA guidelines. The Officer
will be responsible for reviewing documents required for dossiers related to new product registrations, license renewals, and variations for various markets, including the US, Europe, Canada, Australia, and others.Key Responsibilities:
- Review documents for regulatory submissions, ensuring timely availability of data for corporate regulatory submissions and 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.
- Review and approve technical documents such as batch manufacturing records and stability data.
- Coordinate with internal departments (R&D, QA, QC, Production, Purchase) to gather necessary documents for regulatory submissions.
- Stay updated with evolving national and international legislation and provide strategic advice on regulatory matters.
- Assist the Quality team in preparing and managing audits and inspections by regulatory bodies.
- Ensure adherence to GMP, GCP, and Site SOPs at the manufacturing site.
Eligibility Criteria:
Educational qualifications: 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, Track wise, MSB & OpenText for QMS approvals, and MS Office for preparation of regulatory documents.
This is a valuable opportunity for professionals seeking Regulatory Affairs Jobs with a leading pharmaceutical company. Glenmark offers a platform to develop expertise in global regulations, pharmaceutical compliance, and regulatory operations. Candidates with Chemistry, Life Science, B.Pharm, or M.Pharm backgrounds can explore this opportunity through Glenmark Careers and build a successful career in one of the most important functions of the pharmaceutical industry.
Rasayanika is a career information portal and is not the recruiter for this position. All details are sourced from the official notification. Candidates should verify eligibility and deadlines on the official website before applying.
