Role Summary

Responsible for regulatory strategy and CMC submission support for biologics development, clinical, and commercial programs in a CDMO environment.

Candidate Profile

- 12 to 16 years of regulatory affairs experience, preferably in biologics/ biologics CDMO.
- Sound knowledge of global biologics CMC requirements and ICH guidelines.
- Experience in regulatory submissions and client-facing projects.
- Solid scientific writing, communication, coordination, and project-management skills.

Key Responsibilities

- Prepare and review CMC sections for IND, BLA, MAA etc. and other regulatory submissions.
- Liaison with IBSC, RCGM, GEAC, CDSCO and similar regulatory agencies as per requirement.
- Provide regulatory guidance for process and analytical development, technology transfer, validation, comparability, and lifecycle changes.
- Review specifications, stability protocol/data, development reports, validation documents,



and manufacturing information.
- Coordinate responses to regulatory authority queries and support inspections and client audits.
- Work with clients and internal CMC, manufacturing, quality, analytical, and project-management teams.
- Monitor global regulatory requirements for biologics, biosimilars, mAbs, and ADCs.

Key Competencies

- Strong knowledge of large molecule biologics regulatory aspects and writing skills
- Ability to function independently and manage team
- Ability to manage multiple client programs and timelines
- Effective client communication and stakeholder management
- Strong cross-functional collaboration and problem-solving abilities
- Ability to interpret data from a regulatory perspective

📌 Regulatory Affairs - Manager / Senior Manager (Hyderabad)
🏢 Biological E
📍 Hyderabad