Global Regulatory Manager, Business Operations for Global Regulatory Strategy & 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.
- Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
- Maintain tracking data for health authority meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports
- Provide operational support on strategic regulatory documents to help drive timely deliverables
- Drive operational excellence in Global Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency
- Additional responsibilities, in conjunction with regional and/or global regulatory leads, include:
- IND, BLA, and NDA maintenance submissions
- Safety and Annual report submissions (regulatory components)
- Coordinating and driving rapid response team meetings to ensure quality and timely responses to health authority queries. This includes the preparation of response to HA queries according to the rapid response process.
- Maintaining global submission plans and supporting those plans can be executed on time
- Coordinating and driving global regulatory subteam meetings to ensure high quality meeting discussions & outputs; this includes diligent follow-up with Subteam members to uphold accountabilities and drive decision-making
- Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary).
- 1-3 years of pharmaceutical industry experience. Ideally 1 year in regulatory affairs or 2-3 years in a complementary functional area (eg, clinical research)
- Working knowledge of regulatory procedures (US or other)
- Demonstrates a high-level of self-motivation and professional commitment. Indirect management experience of people or major projects.
- Ability to rapidly adapt to different issues and projects at one time. Good interpersonal skills.
- Excellent communication skills.
- Comprehensive understanding of the pharmaceutical industry.
- Comfortable working in a fast-paced environment where speed is paramount
- Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
- Ability to recognize, articulate, and accept calculated risks to make informed decisions
- Willingness and ability to effectively work in a highly matrixed team environment
- Develop understanding of different TAs due to assignment to different projects.
- Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape.
- Increased exposure to global and multi-functional teams.
- Strong team player with ability to seamlessly collaborate across functional and geographic boundaries to achieve company’s goals
- Strong attention to detail
- Thrives on seeking and incorporating constructive feedback
- Communicates opinions, facts and thoughts with clarity, transparency and honesty
- Demonstrates ownership of results within (and beyond) area of responsibility.
- Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
- Looks for opportunities for continuous improvement.
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.
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