Bristol-Myers Squibb Company

Regulatory Policy Director: Global Pediatric Policy and Drug Development

Location
Princeton, NJ, US
Posted
Sep 20, 2018
Ref
R1508598
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Regulatory Policy Director is an experienced Pharma/Regulatory leader with special expertise in Pediatric Drug Development and Policy. The Director serves as a key resource and advisor to a broad range of BMS partners in Research and Development, leveraging strengths in communication, building connections and interpreting the Regulatory environment. The Director provides general education on pediatric drug development pathways and provides project level consultations. The Director represents BMS at internal and external policy groups and partners with other regulatory and policy leads within BMS. This role reports into the Head of Global Regulatory Policy.

  • Develop and maintain expertise of pediatric requirements/incentives, guidance documents relevant to pediatrics, education (internally/externally), pediatric policy globally, and internal company pediatric development.
  • Provide internal education on all aspects of pediatric drug development through online training, SharePoint, lunch and learns, attending individual team/department meetings, and routine email communications.
  • Support and guide project teams as needed in Innovative Medicines Development (both development and marketed products) for US Regulatory interactions related to any aspect of Pediatric Development; liaise with counter-part on Oncology Pediatric Development Team to ensure consistency
  • Provide regulatory strategic guidance into the development of overall company pediatric strategies
  • Develop and maintain relationship with Pediatric Staff at FDA
  • Representative on Pediatric Committee of Industry organizations, BIO and PhRMA, to influence issues in pediatric policy
  • Coordinate with policy groups on issues related to pediatric regulations/policies to ensure BMS position is accurately reflected
  • Participate in external working groups specific to any aspect of Pediatric drug development as appropriate
  • Develop and maintain relationships with key Pediatric Advocacy organizations to understand and address (as possible) the needs
  • Participate in discussions regarding pediatric Public Private Partnerships, to bring back critical information with assessment of need to have BMS support/become member


Qualifications

PhD, MD or MS with 10+ years in the pharmaceutical industry and 5+ years of relevant global regulatory experience. *Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives. *Experience with pediatric drug development including regulatory requirements. *Experience with communication of strategy, issues, and risks in written and verbal format. *Understanding of global regulatory requirements as well as strategic and tactical aspects of drug development.