Bristol-Myers Squibb Company

Global Regulatory Lead

Location
Princeton, NJ, US
Posted
Oct 30, 2018
Ref
R1511191
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.

Job Description:

Global Regulatory Strategy Lead (GRTL) Marketed Product Development will have leadership responsibility for global regulatory strategy within the Innovative Medicine portfolio. Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers. Develop target labeling and co-lead the cross functional labeling team. Ensure consistent positions are presented in responses to global Health Authority (HA) queries. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the GRT, develop global submission plans and HA interaction plans. Provide input into the development of protocol synopses and protocols. Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.

Qualifications
  • PhD, MD or MS with 5+ years in the pharmaceutical industry.
  • Experience in successfully leading teams; ability to broadly represent Marketed Product Development functions on project team.
  • Experience as a member of GRTs, project working groups, or comparable experience.
  • Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
  • Experience with communication of regulatory strategy, issues, and risks in written and verbal format to MPD SLT and other governing bodies.
  • Experience utilizing leadership techniques to drive a team through the stages of team development.
  • Experience coordinating communications within teams and across functions.
  • Experience applying project management techniques within teams.
  • Experience in effectively managing meetings.
  • Demonstrated ability to breakdown complex, scientific content into logical components.
  • Demonstrated ability to coordinate global activities.
  • Demonstrated ability to facilitate issue resolution and I conflict management.
  • Demonstrated ability to drive quality decision-making. Demonstrated ability to organize/prioritize tasks.
  • Demonstrated ability to negotiate with and influence others.
  • Understanding of strategic and tactical role of MPD in the drug development process.
  • Understanding of general global regulatory requirements for drugs in development.
  • Understanding of PD&C process and specific MPD responsibilities/deliverables at PD&C Decision Points