Senior Specialist, Global Regulatory Sciences, UK and Ireland in Uxbridge

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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

• 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.

Verity System SME Leadership (Approx. 50% of Role)

• 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.

External Engagement & Regulatory Intelligence

• 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.

Skills & Experience

• University degree in medical, pharmaceutical, life sciences, or a related discipline.
• 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.
• Strong knowledge of EU, UK, and Ireland regulatory processes, GxP, and quality systems.
• Demonstrated success in developing and executing regulatory strategies for complex products and portfolios.
• Significant experience with regulatory information management systems (e.g., Verity or similar Regulatory Information Management system), including system administration and optimisation.
• Excellent communication, negotiation, and stakeholder engagement abilities.
• Strategic thinker with strong analytical, problem-solving, and decision-making skills.
• Ability to work effectively in a matrixed, cross-functional, and fast-paced environment.

Benefits

• Competitive salary and comprehensive benefits package.
• Hybrid working options available.
• Opportunities for professional development, leadership training, and career progression.
• Supportive, inclusive, and innovative work environment.