Bristol-Myers Squibb Company

Associate Director Regulatory & Compliance International Product Registration/TSE

Location
Hopewell, NJ, US
Posted
Jun 22, 2018
Ref
R1505500
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
• Provide regulatory leadership to support business teams with guidance and strategic solutions on TSE matters
• Evaluate TSE documentation for compliance and prepare TSE regulatory compliance statements for BMS products
• Prepare/review TSE sections of regulatory filings and respond to related Health Authority questions
• Review and provide assessment of manufacturing change controls as they relate to TSE
• Support International Product Registration (IPR) responsibilities for development through lifecycle management, including the registrational sample process
• Support Medical Information program relating to marketed products
• Utilize electronic systems for review and creation of TSE related documents, coordination/tracking of registrational samples and medical information
• Develop, implement and maintain systems and processes related to company TSE program
• Independently manage and prioritize multiple complex projects
• Establish effective working relationships with business units and key business partners to achieve assigned objectives
• Communicate new requirements/trends and identify possible regulatory opportunities and risks to our business partners
• Potential talent management responsibilities

Job Requirements/Education:
• Minimum of Bachelor's Degree scientific discipline (chemistry or pharmacy preferred) with 7-10+ years pharmaceutical industry experience - prefer multi-disciplined, 6+ years CMC regulatory, TSE or IPR related experience
• Strong oral and written communication skills with the ability to effectively impact project teams with strategic solutions to issues. Participate or lead multifunctional teams related to TSE
• Proficient navigation of electronic systems, including formatting and electronic management of data and information
• Ability to interpret global TSE regulations and guidances, including proficient use of resources to stay current with emerging standards and regulations
• Understanding of the drug development process plus an integrated view of the technical, manufacturing and commercial aspects of the pharmaceutical business
• Manage and prioritize multiple projects and complex assignments independently
• Proficient with electronic systems
• Experience in TSE, CMC regulatory and/or GMP auditing a plus
• Managerial experience a plus