Bristol-Myers Squibb Company

Lead, Marketed Product Development Regulatory Strategy

Location
Princeton, NJ, US
Posted
Jul 10, 2018
Ref
R1121771
Required Education
Doctorate/PHD/MD
Position Type
Full time
Provides regulatory leadership to support the Marketed Product Development portfolio based on a solid understanding of the disease, science, and regulations; Recognized as a Leader in Regulatory Science and credible representative of GRS voice to senior management. Provides management oversight and leadership to the Marketed Product Development strategy team of Global Regulatory Team Leaders (GRTLs) and Health Authority Liaisons (USLs) across multiple projects; Provides ongoing feedback, coaching, and career development support to staff in order to maximize their potential. Through oversight of GRTLs and USLs ensures successful negotiation strategies and execution of interactions with the

FDA and/or other global health authorities. Establishes close working relationships with regional strategist and collaborates in strategic meetings with health authorities outside US/EU. Guides the preparation of effective, persuasive presentations to regulatory authorities and creates clear and concise documents regarding regulatory strategy for senior management; Represents the Company in key interactions with Health Authorities; Provides strategic direction of dossier content to ensure that knowledge of the drug, disease, regulatory requirements, and idiosyncrasies of regulatory authorities are incorporated; Remains on the forefront of the relevant science and competitive landscape including detailed competitive intelligence and is viewed as an expert in its application to the regulatory process.

Advanced scientific (mainly clinical) knowledge related to the Marketed Product Development projects. The incumbent will have diverse and sufficient technical expertise to be a credible interface to all development and business partners (CMC, preclinical, clinical, statistician, market access specialists, Legal, etc.); In depth experience in pharmaceutical product development;

Significant direct experience in Liaison activities; Broad specific intelligence of regulatory environment across key regions, anticipation of future trends and impact; Ability to create, develop and communicate well reasoned development and negotiation strategies; Strategic vision and time horizon; ability to integrate various perspectives and transform complexity into actionable action plans; ability to generate alternatives and assess benefits and risks; Recognized as a leader in Global Regulatory Science field and/or with senior management in the BMS operating committees. Successful track record of NME approvals in the US and globally; experience with biologics and chemical NME registration preferred; Expertise in a range of therapeutic areas and the regulatory process; Expert liaison with USFDA, able to interact with senior FDA review officials, and guide negotiation strategy with other health authorities; Mastery of US and global regulatory processes/practices and the idiosyncrasies of various global health authorities; Successful track record of leading cross-functional teams; PhD or MD, with 1O+ years of regulatory.