Bristol-Myers Squibb Company

Associate Director, Global Regulatory Strategy Lead Immuno - Oncology

Location
Princeton, NJ, US
Posted
Oct 27, 2018
Ref
R1506490
Required Education
Doctorate/PHD/MD
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.

  • Associate Director Regulatory Oncology

    Responsibilities
  • Develop US or global regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs and company objectives.
  • Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities
  • Anticipate and interpret key trends and changes in the U.S./global regulatory environment and provide strategic guidance regarding development plans as a result.
  • Foster positive relationships with FDA.
  • Build and maintain a strong, collaborative relationship with all key stakeholders including U.S. Commercial, U.S. Medical Affairs, U.S. Promotion & Compliance, Global Development and other functions key to the success of product development.
  • Interact routinely and will develop a strong team environment with colleagues throughout GRS

Qualifications
  • Ph.D., M.D., PharmD. , MS or commensurate experience with significant experience in Us regulatory affairs (e.g. > 4 years)
  • Good understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
  • Good understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology.
  • Direct experience in developing strategy and leading teams through interactions with FDA/global regulatory agencies.
  • Ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals