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 professional 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

1. Prepare, review, and submit regulatory dossiers for global markets including US FDA and EMA.
2. Author and review CTD/eCTD modules with a strong focus on CMC documentation for biologics and biosimilars.
3. Support preparation and submission of IND, IMPD, BLA, MAA, and other regulatory applications as applicable.
4. Coordinate and manage responses to regulatory agency queries, deficiency letters, and information requests within defined timelines.

Regulatory Strategy & Development Support

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

Lifecycle Management

1. Manage post-approval regulatory activities including variations, supplements, renewals,



annual reports, labeling updates, and change management submissions.
2. Evaluate change controls to identify regulatory impact and determine submission requirements across global markets.
3. Ensure timely implementation of approved changes in compliance with regional regulatory requirements.

Cross-Functional Collaboration

1. Collaborate closely with R&D;, Process Development, Analytical Development, Manufacturing, Quality Assurance, Clinical, and Pharmacovigilance functions.
2. Participate in project discussions, technical reviews, and governance meetings to provide regulatory guidance and risk assessments.
3. Support global development and commercialization objectives through proactive regulatory planning and execution.

Compliance & Inspection Readiness

1. Ensure compliance with global regulatory requirements, ICH guidelines, and biosimilar development pathways.
2. Support inspection readiness activities and contribute to preparation for regulatory audits and inspections by health authorities.
3. Maintain regulatory documentation in accordance with internal procedures and global compliance standards.

Regulatory Intelligence

1. Track and analyze evolving regulations, guidelines, and industry trends related to biologics and biosimilars.
2. Provide regulatory intelligence and strategic recommendations to stakeholders.
3.



Support implementation and effective utilization of regulatory information management systems and document management platforms.

Preferred Experience & Skills

1. Hands-on experience in Regulatory Affairs for Biologics and Biosimilars.
2. Solid understanding of biologics CMC requirements, including:

- Cell Line Development
- Upstream & Downstream Processing
- Analytical Characterization
- Specifications & Control Strategies
- Process Validation
- Comparability Protocols

1. Experience in preparing and reviewing submissions for US FDA and EMA markets.
2. Familiarity with biosimilar regulatory pathways, including US FDA 351(k), EMA Biosimilar Guidelines, and applicable ICH requirements.
3. Experience managing post-approval lifecycle activities for biologic products.
4. Strong analytical, communication, and stakeholder management skills.
5. Ability to interpret complex regulatory requirements and provide strategic guidance to development teams.
6. Experience in sterile injectables, oncology, immunology, or specialty biologics will be an added advantage.

Why Join Us?

This role offers the opportunity to work on cutting-edge biologics and biosimilars programs while collaborating with global teams and contributing to products that impact patient lives worldwide.

Interested candidates are encouraged to apply and become part of our growing Regulatory Affairs team. Share CV at [email protected] with a cc to [email protected]

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