About the Role:

A leading biopharmaceutical organization is seeking an accomplished regulatory affairs leader to provide strategic oversight for biologics and specialty injectables, including Human Albumin and IVIG. The role involves driving global regulatory strategies, securing timely market authorizations, and ensuring compliance across India, MENA, APAC, LATAM, and ROW markets.

Key Responsibilities:
- Define and execute endtoend regulatory strategies for biologics and specialty injectables across global markets.
- Develop riskbased pathways for early launches, fasttrack approvals, and supply continuity.
- Lead preparation and submission of MAAs, PQDs, CTAs, WHO dossiers, PQVARs, renewals, and postapproval changes.
- Oversee submissions via CDSCO SUGAM, IKBP, NGCMA, and countryspecific portals.
- Manage interactions with CDSCO, DCGI, State Licensing Authorities, RCGM, IBSC, and government testing laboratories.
- Lead WHO, regulatory, and customer inspections in collaboration with QA and manufacturing.




- Provide strategic oversight for GCC, LATAM, and ROW regulatory requirements.
- Collaborate crossfunctionally with R&D;, QA, Manufacturing, Clinical, Medical Affairs, Marketing, and Supply Chain.
- Mentor and lead a regulatory team of 45 professionals.

Candidate Profile:
- 15+ years of progressive experience in Regulatory Affairs, preferably in biologics or sterile injectables.
- Solid knowledge of Human Albumin, IVIG, and advanced therapeutic proteins.
- Handson experience with Indian regulatory authorities (CDSCO, DCGI, RCGM, IBSC, NIB, CDL/CDTL).
- Proven expertise in submissions, lifecycle management, variations, renewals, and postapproval changes.
- Solid understanding of biologics manufacturing, quality systems, biosafety, and global regulatory frameworks.
- Experience in WHO prequalification and multicountry dossier management.

📌 General Manager-Regulatory Affairs (Bengaluru)
🏢 Uberlife Consulting
📍 Bengaluru