Senior Vice President; SVP), Regulatory Affairs

Senior Vice President (SVP), Regulatory Affairs

Location: East Brunswick, New Jersey (Hybrid)- 3 days on-site

We’re seeking an experienced SVP, Regulatory Affairs to lead all global regulatory strategy including CMC, Clinical, and Non‑Clinical approval pathways for a growing mid‑sized pharmaceutical company. This executive role drives end‑to‑end regulatory planning across the development lifecycle and serves as the company’s senior interface with FDA, EMA, and other global health authorities.

• Lead global regulatory strategy across CMC, Clinical, and Non‑Clinical programs from early development through registration.
• Oversee regulatory content and strategy for INDs, CTAs, meeting packages, NDAs/MAAs, labeling, and lifecycle management.
• Provide strategic regulatory guidance to executive leadership and cross‑functional teams (CMC, Clinical Development, Non‑Clinical, Medical, Safety, Biostats, Quality).
• Serve as primary liaison with global regulatory agencies to enable efficient and timely development.
• Build, mentor, and scale a high‑performing Regulatory Affairs team; manage regulatory operations and external partners.

• 15+ years of broad regulatory affairs experience in pharma/biotech, covering CMC, Clinical, and Non‑Clinical development pathways.
• Proven track record of leading interactions with FDA/EMA and contributing to major global filings.
• Advanced scientific degree strongly preferred (PhD, Pharm
  
  D, MD, MS).
• Exceptional leadership, communication, and strategic problem‑solving skills.
• Exceptional strategic thinking with the ability to navigate ambiguity and evolving regulatory landscapes.
• Excellent communication and negotiation skills with regulators and internal stakeholders.
• Executive presence with the ability to influence at all levels of the organization.
• Strong organizational skills and the ability to manage multiple priorities simultaneously.
• Collaborative, transparent leadership style; committed to developing high‑performing teams.

• Base salary of $300-400K
• Opportunity to lead regulatory strategy for a dynamic, innovative mid‑sized pharmaceutical company.
• High visibility across the organization with direct impact on global development and registration pathways.
• Collaborative culture with strong executive support for regulatory excellence.