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Position Summary
The Senior Specialist, Global Regulatory Sciences (GRS) UK & Ireland is responsible for driving regulatory strategy, ensuring compliance, and delivering operational excellence across the product lifecycle. This position plays a critical part in shaping UK and Ireland regulatory approaches, influencing global objectives, and maintaining robust relationships with MHRA and HPRA.
A key aspect of this role is acting as the Verity system Subject Matter Expert (SME), dedicating approximately 50% of working time to leading regulatory data management, system optimization, and compliance initiatives.
Working closely with cross-functional teams, the Senior Specialist champions best practices, provides regulatory insight, and contributes to both the strategic regulatory execution and operational excellence within the GRS UK/IE department.
Key Responsibilities
Strategic Leadership & Regulatory Affairs
1. Lead the development and execution of UK and Ireland regulatory strategies, ensuring alignment with global business objectives and regulatory requirements.
2. Serve as the local regulatory contact for MHRA and HPRA on assigned products, assets and projects.
3. Represent the UK/IE in global regulatory teams, advocating for local needs and influencing global regulatory plans and dossiers.
4. Provide expert guidance and oversight for regulatory submissions, lifecycle management, clinical trial applications, and product information.
5. Anticipate regulatory trends, assess risks, and proactively develop mitigation strategies to support business continuity and compliance.
6. Oversee the review and approval of prescribing information, product labelling, and ensure timely implementation in accordance with local legislation.
7. Lead post-approval product information management, including updates for national compendia and platforms.
8. Drive departmental readiness for audits, inspections, and procedural compliance activities.
9. Foster strong partnerships with Medical, Clinical Operations, Marketing, Health Economics/Market Access, Patient Safety, Quality, Logistics, and Global Regulatory functions.
10. Champion continuous improvement initiatives and regulatory innovation within the department.
Verity System SME Leadership (Approx. 50% of Role)
11. Lead the department’s strategic use of the Verity regulatory information management system, ensuring optimal performance and compliance.
12. Liaise with the Verity Team to ensure system integrity, regulatory alignment, and implementation of best practices.
13. Drive system upgrades, change management, and continuous improvement initiatives.
14. Oversee data integrity, reporting, and support audits and inspections related to system use.
15. Provide guidance and support to colleagues on advanced use of the Verity system.
External Engagement & Regulatory Intelligence
16. Build and maintain strong relationships with external stakeholders, including regulatory authorities, industry bodies, and partners.
17. Represent the organisation at external meetings, conferences, and regulatory forums.
18. Monitor regulatory intelligence, policy developments, and competitive landscape to inform strategy and decision-making.
Skills & Experience
19. University degree in medical, pharmaceutical, life sciences, or a related discipline.
20. 2+ years’ experience in regulatory affairs, with proven experience in managing regulatory submissions, clinical trial applications, product lifecycle management and direct interactions with UK and IE regulatory authorities.
21. Strong knowledge of EU, UK, and Ireland regulatory processes, GxP, and quality systems.
22. Demonstrated success in developing and executing regulatory strategies for complex products and portfolios.
23. Significant experience with regulatory information management systems (e.g., Verity or similar Regulatory Information Management system), including system administration and optimisation.
24. Excellent communication, negotiation, and stakeholder engagement abilities.
25. Strategic thinker with strong analytical, problem-solving, and decision-making skills.
26. Ability to work effectively in a matrixed, cross-functional, and fast-paced environment.
Benefits
27. Competitive salary and comprehensive benefits package.
28. Hybrid working options available.
29. Opportunities for professional development, leadership training, and career progression.
30. Supportive, inclusive, and innovative work environment.