Specialist Regulatory Affairs - NBE

Specialist – Regulatory Affairs Novel Biological Entity is responsible for driving global regulatory strategy, submission planning, and lifecycle management for novel biological products across key emerging markets. The role involves close collaboration with cross-functional teams to ensure timely approvals, compliance with regulatory requirements, and successful market entry.

Key Responsibilities:

• Lead end-to-end regulatory activities for innovative biological product portfolios across global markets (Emerging Markets).
• Develop and execute regulatory strategies aligned with business objectives and market requirements.
• Oversee preparation, review, and submission of dossiers (CTD/eCTD) including IND/IMPD/CTA, MAA, variations, amendments, and renewals.
• Act as the primary point of contact with country affiliates and global health authorities for regulatory interactions, queries, and inspections.