Director, Global Regulatory Policy
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Director of Global Regulatory Policy is responsible for driving regulatory policy development and advocacy. The Director provides a strategic view of regulatory policy issues and develops and implements regulatory policy strategy for BMS on assigned priority topics. The role is US focus but with a global mindset and requires cross-functional engagement to develop the regulatory positions. The Director of Regulatory Policy brings an expertise in regulatory affairs and related scientific policy.
Responsibilities include, but are not limited to:
Identifies opportunities to shape and influence changes in the regulatory environment and initiates and leads activities to influence regulatory reform. He/she serves as the lead for regulatory policy throughout the entire life cycle of assigned issues, performs impact assessments, develops action plans and develops or leads the development of BMS positions on assigned regulatory policy issues.
Interprets and shares knowledge of health authority legislation, regulations, guidelines and other Agency documents, collaborates on strategy, and integrating familiarity of BMS development programs and desired policy positions to guide BMS management and colleagues in regulatory affairs to achieve optimal decision-making.
Leads teams to develop BMS positions and responses to draft legislation, guidelines and policies affecting regulatory strategies and plans and manages interactions and communications with trade associations and health authorities on regulatory policy matters.
Represents and advocates on behalf of BMS on broader external networks. Manages effective relationships with internal and external partners to further policy initiatives, including representing BMS with trade associations and other external stakeholders. Represents BMS on industry committees and maintains productive external relationships to ensure productive Agency interactions. Assures BMS’s interests, strategies, positions, or opinions are communicated and contributed in an effective manner.
Shares thorough knowledge of regulatory Agencies, policies, procedures to advance BMS’s familiarity with the Agencies, identifies means to best position and support the company’s regulatory decision-making.
Proactively supports BMS project teams, working collaboratively with regulatory affairs colleagues providing precedents and strategic thinking.
Support initiatives that ensure efficiency in collecting policy-related information and all related activities and accountable for the archival of policy information for use by GRS Staff and cross-functional stakeholders.
Degree / Experience Requirements
Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.). 7 – 10 years pharmaceutical industry or health authority experience, with 5 years in Regulatory affairs and policy
Preparation of presentations, position papers, question and answer documents, articles, and other materials.
Excellent communication and presentation skills with ability to distill critical issues
Strong interpersonal skills with ability to thrive in a cross-functional team environment
Strong team spirit and ability to partner with all stakeholders
Ability to fully demonstrate BMS leadership principles, specifically collaboration, driving results and building talent
Experience in working in the field of pharmaceutical/biotechnology development
Occasional travel (10%) will be required
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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