Senior Director, Regulatory Affairs Team Leader for Immunoscience and Fibrosis (I&F)
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us
Regulatory Affairs Team Leader (Line Manager)
Will be a key member of the GRSP Extended Leadership Team to ensure the development, implementation and alignment of regulatory strategies across projects and the IN&F therapeutic area.
Will be responsible for leading, managing, mentoring, and developing regulatory staff who work on US and/or global projects.
Acts as regulatory representative on various company-wide projects and initiatives.
Support due diligence and business development assessments.
Working with regional regulatory staff as Global Regulatory Leaders and US Regional
Regulatory Leaders on assigned development assets and marketed products:
Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products. Review/provide counsel on product development plans.
Assemble the global regulatory plans for identified projects/products.
Influences and imparts broad expertise regarding US and international regulatory environment. Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects.
Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects.
Serve as the primary interface with health authorities on assigned projects.
Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them.
Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents using internal & external resources. Works with regional international staff for diverse health authority submissions.
Global Project Role (Ad Hoc)
On an as needed basis, provide individual project support as a Global Regulatory Leader and/or US Regional Regulatory Leader on IN&F projects where additional regulatory resources are required.
Skills / Requirements
Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in oncology or inflammatory disease drug development preferred.
8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs. Global experience strongly preferred with command of US experience and EU background desired.
Thorough knowledge of the drug research, development, and commercialization process.
Demonstrated specific expert in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional.
Inter-dependent partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments.
Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Must be able to innovate, analyze and solve critical/complex business problems.
The starting compensation for this job is a range from $202,000-$289,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed. Final individual compensation will be decided based on demonstrated experience. For more on benefits, please visit our https://careers.bms.com/working-with-us. Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location.
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 firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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