Regulatory Policy and Project Manager

Bristol Myers Squibb ,
Uxbridge, Greater London
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Job Description

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. The Regulatory Policy and Project Manager is a regulatory affairs specialist with project management capabilities who has responsibility for the management and leadership on the end-to-end planning, coordination, and high-quality execution of assigned projects. Contributes to and/or leads (as assigned), regulatory project(s) and policy strategy, identifying risks and opportunities, proposing mitigations, and managing projects through to completion. Purpose Lead projects and policy initiatives and supports BMS GRS UK/Ireland team to predict and plan regulatory policy solutions to achieve operational excellence Support the BMS GRS UK/Ireland team to achieve clarity on issues (e.g. Brexit), and develop strategies to plan for and mitigate challenges - project manage BMS GRS UK/Ireland Brexit execution Interface with Head GRS UK/Ireland and advise/support decision-making and developing strategies for Brexit - implement the right local regulatory frameworks, plans and processes to ensure readiness for a possible "hard Brexit" Working in partnership with the Senior Regulatory Affairs Manager will execute the GRS UK/Ireland Brexit regulatory strategy Key responsibility for monitoring legislation, guidelines and the UK and Ireland national regulatory environment (e.g. Brexit, CTR implementation, GMO national legislative updates etc.) to maintain company intelligence and awareness, for compliance and best practice, within the BMS GRS UK/Ireland Quality-facing - Interfaces with the UK/Ireland quality team to ensure GRS UK/Ireland team function in compliance with all GxP related activities. Supports with all regulatory activities on local level (UK/Ireland) Collaborates cross functionally with BMS affiliate BU/International/Europe on local regulatory activities for assigned projects Communicates efficiently and effectively with the relevant National Authorities (UK/Ireland). Drives and ensures regulatory compliance with local legislation Acts as the GRS UK/Ireland Procedures and Intelligence Lead Responsibilities Marketing authorisation procedures and variations Project manages and executes a complete review/gap analysis of GRS UK/Ireland regulatory affiliate processes, identifying and driving strategic initiatives such as process improvements, new process implementation and/or departmental projects to enhance efficiency and drive continued compliance within the GRS UK/Ireland RA affiliate team. Collaborates efficiently and effectively with the UK/Ireland Quality and GRS Compliance team to define a robust change control requirement(s) and execute process improvements for the GRS UK/Ireland team - acts as the GRS UK/Ireland regulatory team's quality liaison. Project manages GRS UK/Ireland regulatory activities relating to BREXIT and BMS integration activities. Acts as a link between EU Regulatory and the GRS UK/Ireland to maintain awareness of company regulatory strategy for marketed and developmental portfolio and communicate this to the affiliate (and action where required) Clinical Trial Applications (CTAs) where the local affiliate is the applicant Working in partnership with the GRS UK/Ireland affiliate Clinical Trial Lead: Supports all Health Authority communication regarding CTAs, e.g. initial & follow-up packages, amendments, responses, end of study notifications etc. Provides feedback to the international CTA group to identify missing or incorrect information & optimize CTA package, through pre-submission review. Informs Regulatory Affairs Europe about local country specific requirements Compliance Drives compliance in the GRS UK/Ireland function: Promotes continuous improvement, continually assesses GRS UK/Ireland existing processes and procedure are "fit for purpose" to ensure continued compliance and success of the team in executing its mandate. Performs regular process review and periodic effectiveness checks for GRS UK/Ireland Regulatory processes (SOP/WP) to ensure GRS UK/Ireland RA team's continued compliance with all RA activities. Leads, advices, supports, and project manages all creation and update of GRS UK/Ireland RA SOPs for relevant regulatory and GDPR activities Support RQC ongoing compliance activities and the bimonthly compliance meetings Reimbursement Working in partnership with the Senior Regulatory Affairs Manager: Support

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