Director, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesJob DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area.Primary activities include, but are not limited to:
- Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
- 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 the developmental compounds or marketed products throughout the entire life cycle of the drug.
- Provides leadership as head of the Global Regulatory Team, which coordinates cross-functional regulatory support for development programs and marketed products.
- Represents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chairs meetings between our company and FDA; prepares our company teams for meetings with FDA at all phases of drug development.
- Leads cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
- Coordinates interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments 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, Investigators Brochures before release from our company to external agencies and investigators.
- Represents Global Regulatory Affairs (GR) within internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation and Development Team.
- Conducts initial Investigational New Drug application/Clinical Study Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.
- Participates in regulatory due diligence activities for licensing candidate review and works with business development partners in executing regulatory responsibilities to advance developmental compounds or support marketed products.Qualifications, Skills & ExperienceEducation Minimum Requirements:
- M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline. Other degrees such as master's with substantial experience in regulatory affairs to suggest equivalent ability to function in this position.Required Experience and Skills:
- M.D. with minimum of 3 years relevant drug development or clinical experience required, or
- Ph.D. with minimum of 5 years relevant drug development experience required, or
- 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 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.Preferred Experience and Skills:
- Substantial experience in regulatory affairs.
- Therapeutic area experience in vaccines or infectious diseases. Experience with antibacterial, antifungal or antiviral agents. #J-18808-Ljbffr