Regulatory Policy Director: Global Pediatric Policy and Drug Development
- Employer
- Bristol Myers Squibb Company
- Location
- Princeton, NJ, US
- Start date
- Jan 15, 2019
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- Discipline
- Regulatory, Regulatory Affairs, Science/R&D, Pharmacology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
- 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.
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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