Associate Director, Global Regulatory Sciences, Precision Medicine & Digital Health, Uxbridge
Client:
Bristol Myers Squibb
Location:
Uxbridge, United Kingdom
Job Category:
-
EU work permit required:
Yes
Job Reference:
a7b823b6a314
Job Views:
9
Posted:
26.04.2025
Expiry Date:
10.06.2025
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
1. Lead global regulatory strategy for biomarkers, companion diagnostics, digital health, and devices to support pharmaceutical development.
2. Understand regulatory landscapes, assess risks, and develop filing strategies.
3. Co-lead marketing application submissions for indications at the filing stage, developing content strategies for global dossiers.
4. Ensure consistent responses to global Health Authority queries.
5. Align global development plans with regulatory requirements, developing submission and interaction plans in collaboration with the regulatory team.
6. Contribute to protocol development and respond to Clinical Trial Application (CTA) queries to meet deadlines.
7. Assist in developing target labeling.
Degree / Experience Requirements
1. Bachelor’s degree required; advanced degree preferred (Masters, PhD, PharmD, BSN). At least 5 years in the industry, with 4+ years in US Medical Device Regulatory Affairs.
2. Experience leading teams and representing regulatory functions within project teams.
3. Experience developing regulatory strategies aligned with clinical and marketing plans.
4. Experience with clinical trial assays and communication between diagnostic and drug sponsors.
5. Experience with global regulatory teams and cross-functional communication.
6. Ability to communicate regulatory strategies and issues effectively.
7. Strong project management and organizational skills.
8. Ability to simplify complex scientific content.
9. Experience coordinating global activities and resolving issues.
10. Negotiation and influencing skills.
11. Understanding of drug development and global regulatory requirements.
12. Knowledge of R&D processes and regulatory decision points.
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Created on 26/04/2025 by TN United Kingdom
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