Regulatory Affairs - Manager / Senior Manager

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.
• Strong 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