Bristol-Myers Squibb Company

Manager, Regulatory & Compliance-TSE/IPR

Hopewell, NJ, US
Sep 08, 2018
Required Education
Bachelors Degree
Position Type
Full time
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.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Job Responsibilities:

  • Subject Matter Expert on global Transmissible Spongiform Encephalopathies (TSE) regulatory requirements
  • Prepare TSE Regulatory Compliance statements for BMS products and TSE supporting documentation for regulatory filings
  • Review and provide TSE regulatory assessment of manufacturing change controls
  • Support International Product Registration (IPR) responsibilities for development through lifecycle management, including the registration sample process
  • Potentially support Medical Information program relating to allergens associated with BMS marketed products
  • Support training for and maintenance of TSE Global Data Repository system
  • Utilize electronic systems for review and creation of TSE related documents, coordination/tracking of registration samples, and allergen information
  • Manage relationships with diverse teams and business partners to achieve assigned objectives
  • Communicate new requirements/trends and identify possible regulatory opportunities and risks to our business partners

Job Requirements/Education:
  • Minimum of Bachelor's Degree, scientific discipline, with minimum of 3-5+ years related experience
  • Strong oral and written communication skills
  • Participate on or tactically lead multifunctional teams
  • Knowledge of pharmaceutical development, including drug substance and drug product, analytical methods, and manufacturing processes
  • Manage multiple projects and assignments
  • Proficient with electronic systems
  • Ability to interpret global regulations and guidance
  • Experience in TSE, CMC regulatory and/or GMP auditing a plus