- 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
Requirements
- 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.
Core Competencies
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.
Highest-signal resume keywords
- Global Regulatory Strategy Development
- Regulatory Oversight
- Drug Development Experience
- Leadership in Regulatory Affairs
- Communication with FDA
ATS Optimization Keywords
Hard Skills
- 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
Soft Skills
- Excellent Communication Skills
- Organizational Skills
- Flexibility
- Attention to Detail
- Analytical Skills
Certifications & Qualifications
- M.D.
- Ph.D.
- M.S.
Industry Keywords
- Vaccines
- Infectious Disease
- Regulatory Agencies
- FDA
- Cross-Functional Teams
- Advisory Committees
- Biological Science
- Chemistry
- Clinical Experience
- Regulatory Affairs Europe