Regulatory Affairs - Manager / Senior Manager

Biological E; Turakapally; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Biological E in India is seeking an experienced Regulatory Affairs Leader to strategize CMC submissions for biologics in development, clinical, and commercial programs within a CDMO setup.

The role requires deep knowledge of global biologics CMC requirements and ICH guidelines, with a proven track record in regulatory submissions, client-facing projects, and cross-functional collaboration to ensure timely approvals.

Qualifications

• 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.

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.

Skills

Regulatory affairs

Job description

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