Require Regulatory Affairs Specialist at Hetero Labs Limited - M.Pharm, B.Pharm, MSc Apply

Hetero Drugs is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. Globally renowned, vertically integrated pharmaceutical player engaged in Research and Development (R&D), manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas.

Regulatory Affairs jobs at Hetero Labs Limited

Regulatory Affairs Specialist with 2-8 years of experience to join our dynamic team at HRF-1, Balanagar, Hyderabad. This role is vital in ensuring compliance and supporting our marketing efforts in global markets.

Key Responsibilities
• Prepare and compile DMFs in compliance with regulations for regulatory and semi-regulatory countries.
• Provide necessary documentation support to the Marketing department.
• Collaborate with cross-functional teams (QC, QA, R&D, and Production) to gather and develop documents for API DMF compilation.
• Attend meetings with marketing teams, customers, and plants regarding regulatory issues.
• Develop DMFs for product registration in key markets such as the US, Europe, Brazil, China, and Russia.
• Collect, collate, and evaluate scientific data from plant/R&D.
• Ensure timely planning, coordination, and submission of API DMFs and address deficiencies in EMT markets.
• Review documents for compilation, identifying gaps and ensuring suitability and acceptance.
• Guide cross-functional teams on EMT regulatory strategy and regional requirements.
• Provide timely responses to external customers regarding technical queries and requests.
• Manage the product life cycle effectively.
• Maintain compliance with regulatory requirements.
Qualifications : B.Pharma, M.Pharma, or M.Sc. (Chemistry)