Senior Specialist, Global Regulatory Sciences, UK and Ireland

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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

• 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 departments 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.

#LI-Hybrid

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

Bristol Myers Squibb is Disability Confident Employer

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