Hetero Biopharma Hiring Regulatory Affairs Assistant Manager
Regulatory Affairs Jobs in Hyderabad | Hetero Biopharma Hiring Life Science Postgraduates with 6–8 Years Experience
Explore regulatory career growth with Hetero Biopharma. Apply now for the role of Assistant Manager – Regulatory Affairs Operations for biopharma projects across the Asia region.
Hetero Biopharma Hiring Assistant Manager – Regulatory Affairs (Biopharma) in Hyderabad
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📱 Join Click HereAre you a seasoned regulatory affairs professional with experience in biologics and biosimilars? Hetero Biopharma is actively hiring for the position of Assistant Manager – Regulatory Affairs Operations to support product lifecycle and submission activities across Asian markets.
This is a fantastic opportunity to join a reputed Indian biopharmaceutical company making strides in global healthcare.
Job Role Overview
Position: Assistant Manager – Regulatory Affairs Operations (Asia Region)
- Department: Regulatory Affairs
- Location: Hyderabad, Telangana
- Reports To: General Manager – Regulatory Affairs
- Experience Required: 6–8 Years in biopharma regulatory affairs
- Education Required: Postgraduate in Life Sciences, Biotechnology, Pharmacy, or related field
Key Responsibilities
- Manage regulatory submissions and product lifecycle operations for biopharmaceutical products across the Asia region.
- Prepare and review CTD and ACTD dossiers for product registrations, renewals, and variations.
- Conduct regulatory reviews to ensure compliance with ICH guidelines and country-specific mandates.
- Coordinate internally across RA(CMC), QA, Clinical Affairs, and Manufacturing for timely documentation.
- Support responses to health authority queries and manage post-approval changes.
- Provide regulatory support for GMP inspections, label compliance, and tender documentation.
- Track regulatory projects using dashboards and ensure timely execution.
- Lead labeling updates and ensure alignment with region-specific requirements.
Candidate Requirements
- Strong knowledge of biopharma regulations in Asia – including ASEAN, South Asia, and the Middle East.
- Hands-on experience in analytical methods, biosimilars, and GMP documentation.
- Experience in working with regulatory agencies and managing health authority queries.
- Technical expertise in Quality documentation, CMC, and dossier preparation.
- Excellent organizational, project management, and communication skills.
Courses Considered
- M.Pharm
- M.Sc. (Biotechnology, Life Sciences, Pharmaceutical Sciences)
- Postgraduate Diploma in Regulatory Affairs
Application Details
- Apply Now: Send your updated resume to prathap.s@hetero.com with subject line: Application for Assistant Manager – Regulatory Affairs.
Quick Overview Table
| Company Name | Hetero Biopharma Pvt. Ltd. |
|---|---|
| Vacancy Department | Regulatory Affairs (Biopharma – Asia) |
| Required Education | M.Pharm / M.Sc. / Life Sciences |
| Experience Required | 6–8 Years |
| Location | Hyderabad, Telangana |