Director, Regulatory Affairs Liaison – Vaccines, Infectious Diseases

Responsibilities

• responsible for development and implementation of global regulatory strategy for assigned projects in the Vaccines and Infectious Disease therapeutic area
• provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact
• 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 as they arise with developmental compounds or marketed products throughout the entire life cycle of the drug
• provides leadership as head of the Global Regulatory Team, coordinating cross‑functional regulatory support for development programs and marketed products
• represents the company with external organizations through direct communication with the FDA
• leads cross‑functional efforts to prepare for advisory committees
• coordinates interactions with foreign agencies to support their interactions and provide strategic direction across multiple regions simultaneously
• reviews and provides final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators’ Brochures before release to external agencies and investigators

Requirements

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline
• required experience: M.D. with minimum of 3 years relevant drug development or clinical experience; Ph.D. with minimum of 5 years relevant drug development experience; or M.S. with minimum of 7 years relevant drug development or clinical experience
• excellent communication skills (both oral and written)
• good organizational skills with a proven ability to simultaneously balance diverse 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
• substantial experience in regulatory affairs preferred
• therapeutic area experience in vaccines or infectious diseases preferred
• experience with antibacterial, antifungal or antiviral agents preferred

Certifications & Qualifications

• M.D.
• Ph.D.
• M.S.