Assistant Manager – Regulatory Affairs (Biologics / Biosimilars)

Location: Ahmedabad
Qualification: M.Pharm / M.Sc. / Ph.D. in Biotechnology, Biochemistry, Life Sciences, or related discipline
Experience: 3-10 years in Regulatory Affairs for Biologics/Biosimilars

About the Role
We are seeking a highly motivated Regulatory Affairs skilled to support global regulatory activities for Biologics and Biosimilars across key international markets. The role offers an opportunity to work closely with cross-functional teams on product development, registration, lifecycle management, and global regulatory strategy.

Key Responsibilities

Regulatory Submissions & Documentation
• Prepare, review, and submit regulatory dossiers for global markets including US FDA and EMA.
• Author and review CTD/eCTD modules with a strong focus on CMC documentation for biologics and biosimilars.
• Support preparation and submission of IND, IMPD, BLA, MAA, and other regulatory applications as applicable.
• Coordinate and manage responses to regulatory agency queries, deficiency letters,



and information requests within defined timelines.

Regulatory Strategy & Development Support
• Contribute to regulatory strategies supporting development, registration, and lifecycle management of biologics and biosimilars.
• Support development programs by providing regulatory input on comparability strategies, analytical similarity assessments, clinical development approaches, and CMC requirements.
• Monitor emerging regulatory requirements and assess the impact of new US FDA, EMA, ICH, and global guidelines on development programs.

Lifecycle Management
• Manage post-approval regulatory activities including variations, supplements, renewals, annual reports, labeling updates, and change management submissions.
• Evaluate change controls to identify regulatory impact and determine submission requirements across global markets.
• Ensure timely implementation of approved changes in compliance with regional re

📌 Assistant Manager – Biologics (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad