Sr. Principal Scientist; Sr. Director - Regulatory Liaison

Senior Principal Scientist, Regulatory Affairs Liaison (General Medicine)
Primary Activities

• Oversee worldwide regulatory strategy development and execution for cardiovascular metabolic programs to optimize labeling and achieve shortest time to approval.
• Serve as Global Regulatory Lead (GRL): global single point of contact for regulatory strategy/registration requirements with agencies and subsidiaries for investigational and marketed drugs/biologics across early/late-stage development.
• Provide expert regulatory advice to Early Development/Product Development teams and act as point-of-contact across Global Regulatory Affairs and Clinical Safety.
• Lead the Global Regulatory Team coordinating cross-functional regulatory support for development and marketed products.
• Review/approve local registration study protocols for secondary-market marketing authorization.
• Communicate with FDA (calls/emails), chair meetings, and prepare teams for FDA meetings.
• Coordinate agency interactions across regions (Europe/International/subsidiary registration departments).
• Review/approve Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before external release.
• Conduct initial IND/CSA content review/approval; participate in regulatory due diligence for licensing candidates.

• Degree in biological science or related discipline.
• B.S./M.S. with 10+ years relevant drug development experience (majority in regulatory affairs).
• M.D. with 7+ years (5+ in regulatory affairs). PhD/PharmD with 7+ years (5+ in regulatory affairs).

• Ability to achieve optimal results with limited day-to-day direction.
• Strong interpersonal, verbal/written communication, and negotiation.
• Demonstrated leadership (building/leading high-performing teams).

• Cardiovascular/renal/respiratory experience (incl. pediatrics, orphan, expedited development).
• Global regulatory experience (EU/China/Japan); prior GRL oversight (IND/CTAs, NDA/BLAs).
• Small/large molecule experience; device knowledge; AI application proficiency.

• Eligible for annual bonus and long-term incentive.
• Comprehensive benefits package (medical/dental/vision, retirement/401(k), paid holidays/vacation, and sick/compassionate days).

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