Kaye/Bassman International ยท 1 day ago
Senior Vice President, Regulatory Affairs
Parsippany, NJ
Full-time
Hybrid
Director/Executive
15+ years expKaye/Bassman International is a commercial-stage leader in non-opioid pain management and regenerative health solutions. They are seeking a Senior Vice President of Regulatory Affairs to lead regulatory strategy across commercial products and development programs while serving as a trusted advisor to the executive team and Board.
ConsultingHuman Resources
Hiring Manager
Edward Canning
Responsibilities
Define and execute comprehensive U.S. and global regulatory strategies aligned with corporate growth objectives
Serve as a trusted advisor to the CEO, Executive Leadership Team, and Board of Directors on regulatory risk, opportunity, and evolving global requirements
Act as the primary regulatory spokesperson with the FDA, EMA, and other global health authorities
Evaluate, strengthen, and scale regulatory capabilities, processes, and talent as the organization grows
Oversee timely, high-quality regulatory submissions for commercial products and pipeline programs
Lead strategies to expedite development and approval for innovative therapies, including emerging modalities
Guide lifecycle management initiatives, including label expansions, line extensions, and post-marketing commitments
Ensure regulatory compliance across development, commercialization, and promotional activities
Build, lead, and develop a high-performing global Regulatory Affairs organization
Partner closely with R&D, Clinical, CMC/Tech Ops, Quality, Medical, Legal, and Commercial teams
Foster a culture of accountability, collaboration, and innovation
Qualification
Required
Advanced degree (PhD, PharmD, MD, or equivalent) in life sciences, pharmacy, or medicine
15+ years of progressive regulatory leadership experience within the biopharmaceutical industry
Proven success leading regulatory strategy for both development-stage and commercial products
Strong experience with FDA and international health authority interactions at senior levels
Track record of regulatory approvals for small molecules and biologics; experience with combination products and devices preferred
Executive presence with strong communication, negotiation, and influencing skills
Preferred
Track record of regulatory approvals for small molecules and biologics; experience with combination products and devices preferred
Exposure to gene therapy or emerging modalities is highly desirable
Experience in musculoskeletal pain, CNS, rheumatology, or adjacent therapeutic areas preferred
Company
Kaye/Bassman International
Kaye/Bassman International is a staffing and recruiting company that offers executive search and professional recruitment.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Jeff Kaye
Co-C.E.O.
Recent News
2024-11-16
Company data provided by crunchbase