Role Summary

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

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
Robust cross-functional collaboration and problem-solving abilities
Ability to interpret data from a regulatory perspective

📌 Regulatory Affairs Manager / Senior Manager Hyderabad
🏢 Biological E
📍 Hyderabad