Bristol Myers Squibb Princeton , NJ 08544
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.
The Global Regulatory Policy Director will collaborate with internal and external stakeholders to manage the capture and review of regulatory policies and oversee the Policy Evaluation and Regulatory Landscape (PEARL) process. This will include working with peers across the BMS footprint as well as engaging the appropriate subject matter expert teams from RD and GPS to determine the impact and relevance of the policy on our drug development and manufacturing. The Director is also responsible for managing and articulating BMS's position on regulatory policies emanating from our International footprint (rest of world).
This role will assess the impact of these policies on our global regulatory strategies and where appropriate advocate for regulatory policies that advance the development of novel therapies and support modern science-based review by global Health Authorities.
As a member of the Bristol-Myers Squibb's Global Regulatory Policy (GRP) group, the Director is responsible for managing and articulating BMS's position on regulatory policies emanating from our International footprint (rest of world). This role will assess the impact of these policies on our global regulatory strategies and where appropriate advocate for regulatory policies that advance the development of novel therapies and support modern science-based review by global Health Authorities.
Communicate key insights and intelligence to BMS colleagues and regulatory leadership
Serve as an international regulatory policy expert on select priority topics
Manage the tracking of new policies and coordinate with BMS subject-matter experts to develop BMS position, response and implementation
Manage internal cross-disciplinary working groups to align on consensus BMS positions and actions on various regulatory issues. Assist in communicating and presenting regulatory best-practices across the organization
Maintain relationships with industry stakeholders (e.g., trade associations, biopharmaceutical companies, regulatory authorities) to gather insights that inform BMS business objectives
Promote international harmonization and convergence of regulatory requirements, as appropriate
Conduct research projects on select topics and develop policy positions or issue briefs
Support BMS working teams with policy interpretation and guidance
PhD, or MS with 10+ years in the pharmaceutical industry and 5+ years of relevant global regulatory experience.
Understanding of global regulatory requirements as well as strategic and tactical aspects of drug development.
Experience with developing regulatory strategies reflecting the global health authority thinking
Experience with communicating strategy, issues, and risks in written and verbal format.
Knowledge of global Health Authorities: including organization and process including key regulatory policy issues.
Ability to partner effectively across the company with senior management, regulatory law, subject matter experts, and corporate affairs.
Ability to successfully influence and advocate on behalf of the company's regulatory policy priorities.
Strong writing and verbal communication skills.
Comfort working independently and within cross-functional teams. Ability to operate in both strategic and tactical settings.