Director, Global Regulatory Lead
4 weeks ago
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.
Position Responsibilities
Leadership responsibility for global regulatory strategy within a development team (DT). Serve as team lead or co-lead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers. Support the preparation of, and participate in / lead (as appropriate), key HA interactions. Assure consistent positions on common issues are presented to global HA. Review and approve content of responses to queries from HAs for respective regions/countries Prepare content for regulatory strategic documentation and Regulatory Project Reviews. Align regulatory plans with commercial and development plans Develop target labeling and co-lead the cross-functional labeling team. Ensure consistent positions are presented in responses to global health authority (HA) queries. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans. Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc. Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.Degree Requirements
Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
Experience Requirements
Significant experience in regulatory affairs (e.g. > 4-7 years)
Key Competency Requirements
Required:
Understanding of scientific content and complexities and good knowledge of Oncology drug development is desired. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process. Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval. Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment. Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks. Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities. Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components. Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies. Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities. Experience as a member of GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions). Experience utilizing leadership techniques to drive a team through the stages of team development.Other Qualifications:
Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals. 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. Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
-
Uxbridge, United Kingdom Bristol Myers Squibb Full timeWorking 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...
-
Associate Director, Global Regulatory Sciences
2 weeks ago
Uxbridge, United Kingdom Bristol Myers Squibb Full timeWorking 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...
-
Uxbridge, United Kingdom Bristol-Myers Squibb Full timeAssociate Director, Global Regulatory Sciences, Precision Medicine & Digital Health at Bristol Myers SquibbChallenging. Meaningful. Life-changing. That's how we describe working at Bristol Myers Squibb. We're not your average company. Every day, in every department, we're doing unique and impactful work. Whether it's optimizing a production line or making...
-
Associate Director, Global Regulatory Sciences
4 weeks ago
Uxbridge, United Kingdom Bristol-Myers Squibb Full time**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...
-
Regulatory Affairs Consultant
1 month ago
Uxbridge, United Kingdom Parexel Full timeWhen our values align, there's no limit to what we can achieve. The purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally. As the Global Labelling Lead , you would...
-
Regulatory Affairs Manager
3 weeks ago
Uxbridge, United Kingdom PE Global Full timePE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract.In order to make an application, simply read through the following job description and make sure to attach relevant documents.Responsibilities of the role: Advising the GRT on regional...
-
Regulatory Affairs Manager
2 months ago
Uxbridge, United Kingdom PE Global Full timePE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract.In order to make an application, simply read through the following job description and make sure to attach relevant documents.Responsibilities of the role: Advising the GRT on regional...
-
Director Regulatory CMC
3 weeks ago
Uxbridge, United Kingdom Bristol-Myers Squibb Full timeDirector Regulatory CMC - Cell Therapy page is loaded Director Regulatory CMC - Cell Therapy Apply locations Uxbridge - GB time type Full time posted on Posted 30+ Days Ago job requisition id R1579021 Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb...
-
Uxbridge, United Kingdom Bristol-Myers Squibb Full timeAssociate Director, Global Regulatory Sciences, Precision Medicine & Digital Health page is loaded Associate Director, Global Regulatory Sciences, Precision Medicine & Digital Health Apply locations Uxbridge - GB time type Full time posted on Posted 5 Days Ago job requisition id R1581063 Working with Us Challenging. Meaningful. Life-changing. Those...
-
Director Regulatory CMC
1 month ago
Uxbridge, United Kingdom Bristol Myers Squibb Full timeDescription The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments...
-
Director Regulatory CMC
3 weeks ago
Uxbridge, United Kingdom Bristol Myers Squibb Full timeDescription The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments...
-
Director of Policy and Regulatory Affairs
3 weeks ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract. May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. Act as a contact...
-
Director of Policy and Regulatory Affairs
2 months ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract. May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. Act as a contact...
-
Director of Policy and Regulatory Affairs
2 months ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract. May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. Act as a contact...
-
Director of Policy and Regulatory Affairs
3 weeks ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract. May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. Act as a contact...
-
Regulatory Affairs Manager
3 weeks ago
Uxbridge, United Kingdom PE Global Full timeJob Description PE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract. Responsibilities of the role: Advising the GRT on regional considerations in developing strategy Ensuring the regional needs are well defined and implemented...
-
Uxbridge, United Kingdom Bristol Myers Squibb Full timeWorking with UsChallenging. 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...
-
Uxbridge, United Kingdom Bristol Myers Squibb Full timeWorking 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...
-
Uxbridge, United Kingdom Bristol Myers Squibb Full timeWorking 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...
-
Senior Director, Global Labeling Strategy Team Lead
2 months ago
Uxbridge, United Kingdom Bristol Myers Squibb Full timeWorking 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...
