Senior Vice President (SVP), Regulatory Affairs (, NJ, United States)

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.

Key Responsibilities

• 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.

Qualifications

• 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, PharmD, 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.

Offer

• 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.