Principal Scientist, Regulatory Liaison

Role: Regulatory Affairs Headquarters Principal Scientist (Vaccines & Infectious Disease)

• Provide regulatory oversight for assigned products as the single global regulatory point of contact (GRACS and external to GRACS).
• Develop worldwide regulatory strategy to optimize labels and shortest time to approval across multiple indications.
• Advise Product Development Teams and subsidiaries on regulatory issues across the drug life cycle.
• Lead the Global Regulatory Team and coordinate cross-functional regulatory support.
• Communicate directly with FDA (calls/email), chair FDA meetings, and prepare teams for FDA meetings.
• Lead/adapt cross-functional preparation for advisory committees; may speak at committees.
• Coordinate interactions with foreign agencies via Regulatory Affairs Europe and subsidiaries; provide multi-region strategic direction.
• Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures before external release.
• Represent GR on internal committees and conduct initial IND/Clinical Study Agreement content review/approval.
• Participate in regulatory due diligence for licensing candidates and support business development regulatory responsibilities.

Education (minimum)

M.D. or Ph.D. or related doctoral degree; or master’s with substantial regulatory affairs experience.

Required experience/skills

M.D.: 3+ years drug development/clinical; OR Ph.D.: 5+ years; OR M.S.: 7+ years (preference regulatory affairs).

Excellent oral/written communication; strong organization; flexibility; scientific/analytical skills; independent results with limited day-to-day direction.

Preferred

Substantial regulatory affairs experience; vaccines/infectious disease experience (antibacterial/antifungal/antiviral).

Benefits (as stated)

• Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.