Principal Scientist, Regulatory Liaison

• Responsible for development and implementation of global regulatory strategy for assigned projects in the Vaccines and Infectious Disease therapeutic area
• Functions with a high degree of independence and provides regulatory oversight for assigned products
• Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously
• Provides expert advice to Product Development Teams and subsidiaries on regulatory issues
• Provides leadership as head of the Global Regulatory Team
• Represents company with external organizations through direct communication with the FDA
• Leads cross-functional efforts to prepare for advisory committees
• Coordinates interactions with foreign agencies through Regulatory Affairs Europe
• Reviews and provides final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols
• Conducts initial Investigational New Drug application/Clinical Study Agreement content review and approval
• Participates in regulatory due diligence activities for licensing candidate review

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline
• M.D. with minimum of 3 years relevant drug development or clinical experience required
• Ph.D. with minimum of 5 years relevant drug development experience required
• M.S. with minimum of 7 years relevant drug development or clinical experience, preference if this experience is in regulatory affairs
• Excellent communication skills (both oral and written)
• Good organizational skills with a proven ability to simultaneously balance activities or multiple projects
• Flexibility required
• Strong scientific and analytical skills with attention to detail
• Ability to achieve optimal results with limited day-to-day direction from the manager.

Demonstrates expertise in developing and implementing global regulatory strategies for vaccines and infectious diseases, with a strong focus on optimizing product labeling and approval timelines. Possesses advanced scientific knowledge and leadership capabilities to guide cross-functional teams and manage regulatory interactions effectively.

• Global Regulatory Strategy Development
• Regulatory Oversight
• Drug Development Experience
• Leadership in Regulatory Affairs
• Communication with FDA

• Regulatory Strategy
• Drug Development
• Clinical Study Review
• Investigational New Drug Application
• Worldwide Marketing Applications
• Clinical Study Agreement Review
• Regulatory Due Diligence
• Label Optimization
• Product Approval Process
• Regulatory Affairs

• Excellent Communication Skills
• Organizational Skills
• Flexibility
• Attention to Detail
• Analytical Skills

• M.D.
• Ph.D.
• M.S.

• Vaccines
• Infectious Disease
• Regulatory Agencies
• FDA
• Cross-Functional Teams
• Advisory Committees
• Biological Science
• Chemistry
• Clinical Experience
• Regulatory Affairs Europe