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- Tasks: Lead global regulatory strategies for innovative medical products and digital health solutions.
- Company: Join Bristol Myers Squibb, a leader in transforming patient lives through groundbreaking therapies.
- Benefits: Enjoy diverse teams, growth opportunities, and a meaningful career that makes a difference.
- Why this job: Be part of a life-changing mission with unique challenges and the chance to impact healthcare globally.
- Qualifications: Bachelor's degree required; advanced degree preferred with 5+ years in regulatory affairs.
- Other info: EU work permit required; collaborate with high-achieving teams in a dynamic environment.
The predicted salary is between 54000 - 84000 £ per year.
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Associate Director, Global Regulatory Sciences, Precision Medicine & Digital Health, Greater London
Client: Bristol Myers Squibb
Location: Greater London, United Kingdom
EU work permit required: Yes
Job Reference: a7b823b6a314
Job Views: 91
Posted: 03.03.2025
Job Description:
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 to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
- Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
- Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
- 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 sub-team, develop global submission plans and HA interaction plans.
- Provide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
- Contribute in the developing of target labeling.
Degree / Experience Requirements
- Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience.
- Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team development.
- Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor.
- Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functions.
- Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.
- Ability to apply project management techniques within teams and effectively manage meetings.
- Demonstrated ability to breakdown complex, scientific content into logical components.
- Ability to coordinate global activities, facilitate issue resolution and conflict management.
- Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks.
- Demonstrated ability to negotiate with and influence others.
- Understanding of strategic and tactical role for the drug development process.
- Understanding of general global regulatory requirements for drugs in development.
- Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points.
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Associate Director, Global Regulatory Sciences, Precision Medicine & Digital Health employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Global Regulatory Sciences, Precision Medicine & Digital Health
✨Tip Number 1
Familiarize yourself with the latest trends in global regulatory affairs, especially related to biomarkers and digital health. This knowledge will help you engage in meaningful conversations during interviews and demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory sciences community, particularly those who have experience with Bristol Myers Squibb or similar companies. Attend industry conferences or webinars to connect with potential colleagues and learn about their experiences.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led teams through regulatory challenges. Highlight your ability to communicate complex scientific content clearly and effectively, as this is crucial for the role.
✨Tip Number 4
Understand the strategic and tactical roles within the drug development process. Be ready to articulate how your previous experiences align with the responsibilities outlined in the job description, particularly in developing regulatory strategies that support clinical plans.
We think you need these skills to ace Associate Director, Global Regulatory Sciences, Precision Medicine & Digital Health
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Associate Director position. Understand the key responsibilities and required qualifications, especially focusing on regulatory strategy and team leadership.
Tailor Your CV: Customize your CV to highlight relevant experience in global regulatory affairs, particularly in medical devices and digital health. Emphasize your leadership roles and any specific achievements that align with the job requirements.
Craft a Compelling Cover Letter: Write a cover letter that connects your background and skills to the specific needs of Bristol Myers Squibb. Mention your understanding of the regulatory landscape and how your experience can contribute to their mission of transforming patient lives.
Highlight Communication Skills: Since the role requires effective communication of regulatory strategies, ensure you provide examples of how you've successfully communicated complex information to diverse stakeholders in your application materials.
How to prepare for a job interview at TN United Kingdom
✨Understand the Regulatory Landscape
Make sure you have a solid grasp of the current global regulatory environment, especially as it pertains to biomarkers and digital health. Be prepared to discuss how you would assess regulatory risks and develop filing strategies.
✨Showcase Leadership Experience
Highlight your experience in leading teams and projects. Be ready to provide examples of how you've successfully driven a team through various stages of development and how you've represented regulatory functions across different project teams.
✨Communicate Clearly
Since communication is key in this role, practice articulating complex scientific concepts in a clear and concise manner. Prepare to discuss how you've effectively communicated regulatory strategies and issues to governing bodies in both written and verbal formats.
✨Demonstrate Project Management Skills
Be prepared to discuss your experience with project management techniques. Share examples of how you've organized and prioritized tasks within teams, facilitated issue resolution, and managed meetings effectively.
