Location: Hyderabad (or as per company policy)
Industry: Pharmaceutical & Healthcare
Job Type: Full-time
Experience Required: 3–9 years
1. Job Description
Hetero, a global leader in the pharmaceutical industry, is seeking Regulatory Affairs Specialists to join its dynamic team. The role focuses on Formulation markets (ROW, EU, US), ensuring compliance and seamless regulatory approvals.
Key Responsibilities:
- Dossier Preparation & Submissions: Compile and submit regulatory documents for global markets.
- Life Cycle Management (LCM): Maintain and update product registrations.
- Pre & Post Approval Handling: Manage queries from health authorities and ensure timely approvals.
- Market Authorization Applications (MAA) & CMC Expertise: Oversee Chemistry, Manufacturing, and Controls documentation.
Ideal candidates will thrive in a fast-paced environment, leveraging their technical knowledge to drive successful regulatory outcomes.
2. About the Hiring Company
Hetero is a globally recognized pharmaceutical company headquartered in Hyderabad, India, with a strong presence in 150+ countries. Known for its innovation in generic drugs and biosimilars, Hetero is a trusted name in therapies for oncology, HIV, neurology, and more. The company fosters a culture of excellence, offering employees opportunities for professional growth and global exposure.
3. Eligibility Criteria
Educational Qualifications:
- M Pharma / B Pharma / M Sc in a relevant discipline.
Experience & Skills:
- 3–9 years in regulatory affairs, preferably in Formulation (ROW, EU, US markets).
- Proficiency in dossier preparation, LCM, and CMC documentation.
- Strong understanding of ICH, FDA, EMA, and other regulatory guidelines.
- Excellent communication and project management skills.
4. How to Apply
Interested candidates meeting the eligibility criteria can apply via email:
Email: chandrasekhar.r@hetero.com
Subject Line: “Application for Regulatory Affairs Specialist – [Your Name]”
Attachments: Updated CV (PDF/Word format) with relevant details.
Note: Only shortlisted candidates will be contacted for further evaluation.
