Manager Global Regulatory Affairs

We are seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals across US, EU, and emerging markets.

Key Responsibilities

- Develop and implement global regulatory strategies for biologic products across all phases of development, from preclinical to post-marketing. - Ensure alignment between business objectives and regional regulatory requirements (FDA, EMA, and emerging markets). - Prepare, review, and manage high-quality regulatory submissions, including INDs, IMPDs, BLAs, MAAs, CTAs, DSURs, and Annual Reports, as applicable. - Manage post-approval activities, including variations, amendments, and lifecycle management submissions. - Act as a key liaison with global regulatory agencies, addressing queries and facilitating timely product approvals. - Collaborate cross-functionally with R&D, Quality, Clinical, CMC, and national regulatory teams to ensure regulatory compliance throughout the product lifecycle. - Provide regulatory input and guidance during product development, technology transfer, and clinical trial execution. - Monitor, analyze, and interpret evolving global regulatory guidelines, policies, and industry trends relevant to biologics. - Deliver regulatory impact assessments and interpretive analyses of new regulations, guidance documents, and directives affecting product development or CMC operations.

Open Positions :

- Executive

-Assistant Managers

Qualifications & Experience

- Master’s degree (M.Sc., M.Pharm, M.Tech) in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related discipline. - 5–7 years of experience in Regulatory Affairs, with a strong focus on biologics (mAbs, biosimilars, vaccines, or novel biologics). - Proven experience handling regulatory submissions and interactions with FDA, EMA, and emerging market authorities. - Strong working knowledge of ICH guidelines, global regulatory frameworks, and biologics development pathways. - Excellent communication, stakeholder management, and cross-functional collaboration skills.

Why Join Us

- Opportunity to work on innovative biologic programs with global regulatory exposure. - Collaborative, science-driven, and growth-oriented environment.