Newark - Global Regulatory Affair Vice President - Clinical

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.

• 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

A successful 'Global Regulatory Affairs Vice President - Clinical' should have:

• 10+ years of regulatory affairs experience in biopharma, with a focus on metabolic disease indications (diabetes, obesity, etc.).
• Proven track record of successful FDA and EMA interactions drive regulatory approvals.
• Strong expertise in clinical regulatory affairs, particularly in late-stage development and approval processes.
• Experience managing global regulatory submissions and working with cross-functional teams.

• Salary range of $350,000 - $440,000
• Comprehensive benefits package including 401k and medical insurance
• Innovative and embracive company culture
• Extensive career growth opportunities

If you are an experienced clinical Regulatory Affairs expert in the Life Sciences industry and are excited about the opportunity to make a significant impact on a global scale, we encourage you to apply for the 'Global Regulatory Affairs Vice President - Clinical' position.