Senior Specialist, Global Regulatory Sciences and Ireland
Listed on 2026-03-05
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Healthcare
Healthcare Management, Healthcare Administration, Healthcare Compliance
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. 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:
Position SummaryThe 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- Lead the development and execution of UK and Ireland regulatory strategies, ensuring alignment with global business objectives and regulatory requirements.
- Serve as the local regulatory contact for MHRA and HPRA on assigned products, assets and projects.
- Represent the UK/IE in global regulatory teams, advocating for local needs and influencing global regulatory plans and dossiers.
- Provide expert guidance and oversight for regulatory submissions, lifecycle management, clinical trial applications, and product information.
- Anticipate regulatory trends, assess risks, and proactively develop mitigation strategies to support business continuity and compliance.
- Oversee the review and approval of prescribing information, product labelling, and ensure timely implementation in accordance with local legislation.
- Lead post‑approval product information management, including updates for national compendia and platforms.
- Drive departmental readiness for audits, inspections, and procedural compliance activities.
- Foster strong partnerships with Medical, Clinical Operations, Marketing, Health Economics/Market Access, Patient Safety, Quality, Logistics, and Global Regulatory functions.
- Champion continuous improvement initiatives and regulatory innovation within the department.
- Lead the department’s strategic use of the Verity regulatory information management system, ensuring optimal performance and compliance.
- Liaise with the Verity Team to ensure system integrity, regulatory alignment, and implementation of best practices.
- Drive system upgrades, change management, and continuous improvement initiatives.
- Oversee data integrity, reporting, and support audits and inspections related to system use.
- Provide guidance and support to colleagues on advanced use of the Verity system.
- Build and maintain strong relationships with external stakeholders, including regulatory authorities, industry bodies, and partners.
- Represent the organisation at external meetings, conferences, and regulatory forums.
- Monitor regulatory intelligence, policy developments, and competitive landscape to inform strategy and decision‑making.
- University degree in medical, pharmaceutical, life sciences, or a related discipline.
- 2+ years’ experience in regulatory affairs, with proven…
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