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Executive Director
Regulatory Affairs Team Leader, IN&F
Posted on 7/15/2022
INACTIVE
Locations
Toms River, NJ, USA • Princeton, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Leadership
Management
Research
Requirements
  • Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in IN&F or inflammatory disease drug development preferred
  • 12-15 years pharmaceutical industry experience, including 8-10 years in regulatory affairs. Global experience strongly preferred with command of US experience and EU background desired. Thorough knowledge of the drug research, development, and commercialization process
  • Demonstrated specific expert in one or more key areas - Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional. Inter-dependent partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with nondomestic organizations/cross-cultural environments. Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.MD (PhD or other high-level degree optional)
  • Must be able to innovate, analyze and solve critical/complex business problems
  • Demonstrated specific expert in one or more key areas - Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional
  • Inter-dependent partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments
  • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously
  • Must be able to innovate, analyze and solve critical/complex business problems
Responsibilities
  • Responsible for the recruitment, hiring, retention, and development of Regulatory Affairs staff
  • Formulates regulatory strategy in collaboration with the VP, IN&F Global Regulatory Sciences and oversees implementation of activities needed to secure approval of new drugs or approvals for expanded indications across product portfolio
  • Oversee all activities pertaining to interactions with FDA, EMA, and other health authorities and communicates outcomes to Senior Management and relevant governance committees
  • Provides leadership and guidance to senior executives on regulatory matters pertaining to the IN&F Therapeutic Area to improve the effectiveness of regulatory strategies in order to bring new products to regulatory submission and approval in the most expeditious manner
  • Works in close partnership with internal/external key stakeholders to effectively manage project development timelines and expectations
  • Directs due diligence activities related to regulatory affairs and directs activities associated with external alliances
  • Establishes the procedures and resources require to meet our legal and regulatory obligations
  • Provides strategic leadership in business processes and cross-functional partnerships
  • Leads, mentors, and guides development of talent, which includes succession and development planning, performance management, and recognition for the IN&F Regulatory Team
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company mission
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.