 Location: HRF-1, Balanagar, Hyderabad
Position: Regulatory Affairs Specialist
Experience: 2-8 years
Qualifications: B.Pharm, M.Pharm, or M.Sc. (Chemistry)
Company Overview:
Hetero Labs Limited is a leading Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. We specialize in APIs, generics, biosimilars, and branded generics, with a strong commitment to Research and Development (R&D), manufacturing, and marketing high-quality chemical and biologic medicines across diverse therapeutic areas.
Key Responsibilities:
- Prepare and compile Drug Master Files (DMFs) in compliance with regulatory requirements for various countries.
- Provide documentation support to the Marketing department.
- Collaborate with cross-functional teams (Quality Control, Quality Assurance, R&D, and Production) to gather and develop necessary documents for API DMF compilation.
- Attend meetings with marketing teams, customers, and manufacturing plants regarding regulatory issues.
- Develop DMFs for product registration in key markets, including the US, Europe, Brazil, China, and Russia.
- Collect and evaluate scientific data from R&D and production facilities.
- Ensure timely planning, coordination, and submission of API DMFs, addressing deficiencies in emerging markets.
- Review and ensure the suitability of documents for compilation, identifying any gaps.
- Guide cross-functional teams on regulatory strategies and regional requirements.
- Respond promptly to external customer inquiries regarding technical matters.
- Manage product life cycles effectively while maintaining compliance with regulatory requirements.
How to Apply:
Interested candidates are invited to send their updated resume to venkatanaveen.m@hetero.com by 10th October 2024.
Join Hetero Labs and contribute to our mission of improving global health through innovative pharmaceutical solutions!
