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

Are 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
• MSc. (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.

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