Global Regulatory Affair Vice President - Clinical

Global Regulatory Affair Vice President - Clinical

Global Regulatory Affair Vice President - Clinical role at Page Executive. Our client is a large Life Sciences organization known for quality and global presence.

About Our Client

Our client is a large organization in the Life Sciences industry. Known for its innovative approach to quality, they have an established presence globally and continue to make significant contributions to the field of Life Sciences.

Responsibilities

• Develop and execute regulatory strategies for metabolic disease drug development, ensuring compliance with FDA, EMA, and global regulatory requirements.
• Drive interactions with regulatory agencies, including pre-IND / IND submissions, NDA / BLA filings, advisory meetings, and approval processes.
• Oversee clinical regulatory affairs (RA), ensuring alignment between clinical development and regulatory expectations.
• Provide strategic guidance on regulatory pathways, risk assessment, and regulatory trends affecting metabolic disease treatments. Cross-functionally with clinical, medical, and commercial teams to optimize regulatory positioning.
• Manage regulatory submissions, including INDs, CTAs, NDAs, and BLAs, ensuring timely approvals.

The Successful Applicant

What's on Offer

Contact

Quote job ref : JN-022025-6675680

Additional Details

Location : Cranford, NJ

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