Bristol-Myers Squibb Company

Regulatory Policy Manager

Location
Princeton, NJ, US
Posted
Nov 09, 2018
Ref
R1508595
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.

Manage the PEARL process to ensure appropriate review and assessment of global regulatory policies impacting R&D and manufacturing. This encompasses facilitating PEARL team meetings; convening and engaging internal subject matter experts (SMEs) across BMS's global footprint to review, assess and develop BMS response, to priority draft policies as well as assess final regulatory policies. In addition to ensuring the teams determine the best path forward to ensure appropriate implementation of the assessment and recommendations. The manager is responsible for identifying, analyzing and communicating regulatory policy impacting drug development and regulatory strategy on a regular basis. The manager will ensure the PEARL teams include all appropriate subject matter experts, understand the goals of the PEARL process and ensure appropriate follow-up and, as needed, issue escalation. Responsibilities also include ensuring that tools and processes are developed to maximize information gathering, analyses and dissemination.

Qualifications:
  • Minimum 4 -5 years' experience in Pharmaceuticals or Related Field
  • Bachelor degree in Biological Sciences, Chemistry, or Engineering or equivalent

Additional qualifications:
  • Knowledge of international regulatory policies and understanding of global Health Authority (e.g., EMA, MHRA) regulations impacting drug development
  • Experience analyzing, or at a minimum broad exposure to, regulatory policy relevant to the biopharmaceutical industry
  • Proven ability to collate and align disparate comments into a coherent document
  • Proficiency with managing teams comprised of individuals representing different subject matter experts (SMEs)
  • Critical thinking skills in analyzing & exercising judgment on complex issues, with ability to interpret, understand, & effectively communicate complex information clearly, accurately, and concisely under deadline pressure
  • Management Professional (PMP) Certified (is a plus)

Strong project, time, and inter-personal management skills (Project Proficiency in MS Office, Microsoft Project and Collaboration applications such as SharePoint)