Job opportunity for Regulatory Affairs Specialist at Hetero Labs Limited – Apply 10th Oct 2024

About Hetero Labs Limited 

Hetero Drugs, the world’s largest producer of anti-retroviral drugs, is a renowned Indian pharmaceutical company involved in APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. With a strong global presence, we are committed to research, development, manufacturing, and marketing high-quality medicines across diverse therapeutic areas.

Position: Regulatory Affairs Specialist
Location: HRF-1, Balanagar, Hyderabad
Experience: 2-8 years

Key Responsibilities:

• Prepare and compile Drug Master Files (DMFs) in compliance with international regulatory requirements for various markets.
• Provide essential documentation support to the Marketing department for global market registrations.
• Collaborate with QC, QA, R&D, and Production teams to gather and prepare documents for API DMF compilation.
• Participate in meetings with marketing teams, customers, and production plants to address regulatory matters.
• Develop DMFs for key markets, including the US, Europe, Brazil, China, and Russia.
• Collect, organize, and evaluate scientific data from the plant and R&D departments.
• Ensure timely planning and submission of API DMFs and address any deficiencies for emerging markets.
• Review and verify documents for accuracy, identifying gaps and ensuring acceptance by regulatory authorities.
• Guide cross-functional teams on regulatory strategies and regional requirements for specific markets.
• Provide timely responses to technical queries from external customers.
• Effectively manage the product life cycle to ensure ongoing compliance with regulatory standards.

Qualifications:

• B.Pharma, M.Pharma, or M.Sc. in Chemistry

Application Deadline: 10th October 2024
Email your updated resume to: venkatanaveen.m@hetero.com

Join our dynamic team and contribute to shaping the future of global healthcare with Hetero Drugs!

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