Regulatory Affairs Jobs | Glenmark Hiring | Apply Now
A unique opportunity awaits in regulatory affairs jobs at Glenmark Pharmaceuticals, a leader in the life sciences sector. The company is seeking a qualified Officer for Plant Regulatory Affairs in Indore, India. This pivotal role in Glenmark careers involves ensuring compliance with international regulations, contributing to the global reach of Glenmark’s healthcare solutions.
- Position: Officer – Plant Regulatory Affairs
- Location: Pithampur Plant, Indore
- Function: Global Regulatory Affairs
About the Company
Glenmark Pharmaceuticals is a global pharmaceutical company headquartered in India, specializing in the development and manufacture of a wide range of healthcare products. With a strong focus on innovation, Glenmark operates in various therapeutic areas and is committed to improving patient outcomes through high-quality medicines. The company is recognized for its contributions to the life sciences field and maintains a robust presence in international markets.
Key Responsibilities
- Review documents for regulatory submissions and ensure timely availability of required data.
- 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 to gather necessary documents for regulatory submissions.
- Stay updated with evolving national and international legislation and guidelines.
- Assist the Quality team in preparing for audits and inspections by regulatory bodies.
- Ensure adherence to GMP, GCP, and site SOPs at the manufacturing site.
Educational qualifications
Life Sciences 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, attention to detail, and excellent communication skills.
- Systems & Tools: Proficiency in SAP, Trackwise, MSB & OpenText for QMS approvals, and MS Office.
Embark on a rewarding career path with Glenmark Pharmaceuticals, where regulatory affairs jobs and life sciences jobs offer the chance to contribute to cutting-edge healthcare solutions. Glenmark careers are designed for those who aspire to excel in the pharmaceutical industry, ensuring compliance and innovation are at the forefront of their mission. Explore this opportunity to join a team that is dedicated to improving global health outcomes.
