By admin 
🌟 Exciting Opportunity in Regulatory Affairs at Hetero Labs Limited! 🌟
We are seeking a 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)
If you’re passionate about regulatory affairs and want to make a meaningful impact in the pharmaceutical industry, we want to hear from you!
If you’re ready for new challenges, please send your updated resume to venkatanaveen.m@hetero.com
Join us on this exciting journey! ✨