Officer - Plant Regulatory Affairs

Job Description

Officer - Plant Regulatory Affairs

Location: Pithampur Plant, Indore

Position description: A Plant Regulatory Affairs Officer in the Glenmark pharmaceutical acts as the crucial link between the manufacturing plant and Corporate regulatory team, ensuring that all products, processes, and documentation comply with international regulations i.e. ICH, USFDA and EMA guidelines

Primary Responsibilities

Reviewing of documents required for dossiers for new product registrations, license renewals, and variations for US, Europe, Canada, Australia and ROW market. 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.

Review and approve technical documents such as batch manufacturing records, process validation reports, Hold time report, Nitrosamine risk assessment report and stability data etc.

Coordinating with various internal departments (R&D, QA, QC, Production, Purchase, etc.) to gather necessary documents and samples for regulatory submissions and address queries.

Staying current with evolving national and international legislation and guidelines and providing strategic advice to management on regulatory matters and potential risks.

Assisting to Quality team for preparing and managing audits and inspections by national and international regulatory bodies.

Ensure adherence to GMP, GCP, and Site SOPs at the manufacturing site.

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. Skilled in MS Office for preparation of regulatory documents.