Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases

Brief Description of Position Develop and implement global regulatory strategy for assigned Vaccines and Infectious Disease projects. Primary Activities Provide independent regulatory oversight and serve as the single, accountable global regulatory point of contact. Develop worldwide product regulatory strategy to optimize labeling and shorten time to approval for multiple indications. Advise Product Development Teams and subsidiaries across the full product life cycle. Lead the Global Regulatory Team; coordinate cross-functional regulatory support. Communicate with the FDA (calls/e-mail), chair FDA meetings, and prepare internal teams for FDA meetings. Lead preparations for advisory committees; may speak at advisory committees. Coordinate foreign agency interactions (Regulatory Affairs Europe and subsidiary registration teams) and provide multi-region strategic direction. Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures. Represent GR on internal committees for regulatory advice/approvals. Conduct initial IND/Clinical Study Agreement content review and approval. Participate in regulatory due diligence and support licensing and business development regulatory responsibilities. Qualifications Education: M.D. or Ph.D. (or related doctoral degree); or M.S. with substantial regulatory affairs experience. Experience: M.D. (3+ years) or Ph.D. (5+ years) or M.S. (7+ years) in relevant drug development/clinical experience; regulatory affairs preferred. Skills (Required/Preferred) Excellent oral/written communication; strong organizational, analytical, scientific/attention to detail; flexibility; ability to perform with limited day-to-day direction. Preferred: substantial regulatory affairs experience; vaccines/infectious disease experience (antibacterial/antifungal/antiviral). Salary/Benefits & Application Annual bonus and long-term incentive (if applicable); comprehensive benefits include medical/dental/vision, retirement/401(k), paid holidays, vacation, and sick/compassionate days. Apply via (Application deadline per posting.) #J-18808-Ljbffr Scorpion Therapeutics