Senior Director/Director Regulatory Strategy

Responsibilities

• Develop and lead global, integrated regulatory strategies for investigational and marketed products
• Provide strategic input on development plans, target product profiles, and regulatory submissions
• Anticipate and mitigate regulatory risks and identify opportunities for expedited programs
• Lead global regulatory authority interactions including IND/CTA, End-of-Phase, and scientific advice meetings
• Provide strategic oversight for major regulatory filings such as NDAs, BLAs, and MAAs
• Partner with Clinical, CMC, Quality, and Commercial teams to align regulatory strategy with business goals
• Mentor and develop regulatory strategists within a matrixed environment
• Monitor and interpret evolving global regulatory trends and policy changes

Requirements

• Bachelor’s degree required (advanced degree like PhD, PharmD, MD, or MSc preferred)
• 7+ years of progressively responsible experience in Regulatory Affairs within the pharmaceutical industry
• Demonstrated experience leading global regulatory strategies and major submissions
• Proven success in direct interactions with global regulatory authorities
• Experience working in matrixed, cross-functional development teams

Preferred Qualifications

• Experience in therapeutic areas such as immunology, neurology, or rare disease
• Experience with accelerated pathways like Fast Track or Breakthrough Therapy
• Experience supporting global commercialization and post-approval lifecycle activities

Benefits

• Comprehensive health coverage
• Flexible paid time off
• Generous parental leave
• Competitive 401(k)
• Education assistance
• Wellness resources

About the Company

Vor is a biotechnology company focused on tackling autoimmune diseases at their root cause by advancing telitacicept, a dual BAFF/APRIL inhibitor.