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HETERO, one of the world’s leading pharmaceutical organizations, is inviting applications from experienced professionals for the position of Regulatory Affairs Specialist at its Jeedimetla facility in Hyderabad, Telangana. Candidates with expertise in formulation regulatory affairs for ROW, EU, and US markets are encouraged to apply.
This is an excellent opportunity for pharmaceutical professionals looking to advance their careers in global regulatory affairs and contribute to the development of accessible healthcare solutions.
Job Details
- Company: HETERO
- Job Title: Regulatory Affairs Specialist
- Department: Regulatory Affairs (RA)
- Specialization: Formulations
- Job Location: Jeedimetla, Hyderabad, Telangana
- Experience Required: 3–9 Years
- Qualification: M.Pharm / B.Pharm / M.Sc
- Market Exposure: ROW, EU, and US
Key Responsibilities
- Preparation, review, and submission of regulatory dossiers.
- Handling regulatory life cycle management activities.
- Managing pre-approval and post-approval submissions.
- Preparing and managing Marketing Authorization Applications (MAA).
- Handling Chemistry, Manufacturing and Controls (CMC) documentation.
- Ensuring regulatory compliance with applicable global market requirements.
Educational Qualification
Candidates should possess any of the following qualifications:
- M.Pharm
- B.Pharm
- M.Sc
Experience Required
Applicants should have 3–9 years of relevant experience in regulatory affairs, preferably in formulation regulatory affairs with exposure to ROW, EU, and US markets.
How to Apply
Interested and eligible candidates can send their updated CV to the email address below.
Email: sivasai.g@hetero.com
Subject Line: Application for RA
Candidates should highlight their relevant regulatory affairs experience, formulation expertise, and exposure to international regulatory markets in their CV.
About HETERO
HETERO is a global pharmaceutical organization focused on making healthcare accessible to people worldwide. The company promotes a culture of integrity, innovation, collaboration, and excellence.
