Global Regulatory Affairs

Glenmark Pharmaceuticals is seeking qualified professionals for the position of Officer – Plant Regulatory Affairs at its manufacturing facility in Pithampur, Indore. This opportunity is well suited for candidates with a background in pharmacy or life sciences who are interested in regulatory compliance and pharmaceutical manufacturing.

About the Role

The selected candidate will support regulatory activities at the manufacturing site by ensuring that plant documentation, processes, and product-related records comply with international pharmaceutical regulations. The role also involves working closely with corporate regulatory teams and multiple internal departments to facilitate global product registrations and maintain regulatory compliance.

Key Responsibilities

• Prepare, review, and organize regulatory documents required for product registrations, license renewals, and post-approval submissions across global markets.

• Coordinate with manufacturing, quality, research, and other functional teams to collect information required for regulatory filings.

• Evaluate manufacturing changes, deviations, and investigations from a regulatory compliance perspective and recommend appropriate documentation where necessary.

• Assist in preparing regulatory reports and supporting documentation for international health authorities.

• Review technical records, validation reports, stability documentation, manufacturing records, and other quality-related documents before regulatory submission.

• Monitor updates in global pharmaceutical regulations and support the implementation of new regulatory requirements at the manufacturing site.

• Provide assistance during regulatory inspections and quality audits by ensuring the availability of required documents and records.

• Promote compliance with Good Manufacturing Practices (GMP), internal quality systems, and applicable regulatory standards.

Eligibility

Candidates should possess any of the following qualifications:

• B.Pharm

• M.Pharm

• Degree in Life Sciences

• Chemistry

• Other equivalent science-related disciplines

Desired Skills

Applicants should have:

• Knowledge of international pharmaceutical regulatory requirements, including major global guidelines.

• Familiarity with pharmaceutical quality documentation and manufacturing processes.

• Experience using quality management and enterprise software platforms such as SAP or similar systems will be an added advantage.

• Good analytical, documentation, communication, and coordination skills.

• Strong attention to detail and the ability to manage multiple regulatory activities efficiently.