Senior Director, Regulatory Affairs Strategy
6 days ago
Job Description Summary #LI-Hybrid (12 days per month on-site) Location : London (The Westworks) United Kingdom Internal Job Title : Strategy Lead RA Enabling Functions We are seeking a strategic leader to drive planning business process excellence and performance management for our RA Enabling Functions group. Leveraging insights from across Novartis Development and the external landscape you will translate strategy into actionable plans, lead high-impact projects and build lasting strategic capabilities. Strong data management, analytics and thought leadership are essential as is the ability to influence through matrixed leadership. Job Description Major accountabilities : Serve as a subject matter expert maintaining oversight of Regulatory Affairs (RA) activities to support portfolio needs, objectives and project execution. Drive essential processes, analyze KPIs / metrics and provide recommendations to inform resource prioritization and budget allocation for the RA Enabling Functions Leadership Team (EF‑LT). Deliver robust EF‑LT governance enabling timely informed decision-making and effective resource allocation. Enhance EF‑LT effectiveness by managing team processes and introducing tools to build team performance. Lead value‑based projects to transform RA functional health and core competencies. Act as a key liaison and sparring partner to senior stakeholders across RA Development, Biomedical Research and Commercial functions. Develop compelling business cases for leadership endorsement and alignment. Create and manage annual operating plans and management rhythms supporting proactive planning and efficient leadership team operations. Minimum requirements : Fluent in English (oral and written). Significant experience in global strategy innovation or management consulting; specific experience in Regulatory Affairs is preferred. Proven ability to lead and manage people within a global matrix environment. Strong project management skills with a demonstrated ability to optimize ways of working. Solid background in budget finance and resource management within pharmaceutical research and development settings. Demonstrated ability to create strategic objectives and plans based on internal and external assessments. Excellent negotiation and conflict resolution skills strong decision‑making abilities and outstanding written and visual communication skills. Commitment to Diversity & Inclusion Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve. Skills Desired Clinical Trials Cross-Functional Teams Drug Development Lifesciences Negotiation Skills People Management Problem Solving Skills Regulatory Compliance Risk Management Strategy Execution Required Experience : Exec Key Skills Business Development Marketing Pricing Analysis Skills Research Experience Project Management Research & Development Strategic Planning Financial Modeling Leadership Experience Management Consulting Analytics Employment Type : Full-Time Experience : years Vacancy : 1 #J-18808-Ljbffr
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Senior Director, Regulatory Affairs
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London, Greater London, United Kingdom Beacon Therapeutics (USA) Inc Full time £150,000 - £200,000 per yearJoin Beacon Therapeutics (USA) Inc. as a Full-Time Senior Director of Regulatory Affairs and be at the forefront of transformative biotech innovations. This is a unique opportunity to shape regulatory strategies that directly influence the success of groundbreaking therapeutics in the UK market. Here, you will have the chance to leverage your expertise in a...
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Senior Director, Regulatory Affairs
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Greater London, United Kingdom Beacon Therapeutics (USA) Inc Full timeJoin Beacon Therapeutics (USA) Inc. as a Full-Time Senior Director of Regulatory Affairs and be at the forefront of transformative biotech innovations. This is a unique opportunity to shape regulatory strategies that directly influence the success of groundbreaking therapeutics in the UK market. Here, you will have the chance to leverage your expertise in a...
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Senior Regulatory Affairs Director
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Greater London, United Kingdom Beacon Therapeutics Full timeA leading biotech firm is seeking a Senior Director of Regulatory Affairs to lead regulatory strategies for innovative products in the UK. This role involves spearheading EU and UK filing processes and providing essential regulatory leadership. Candidates should have significant experience in regulatory affairs, particularly in biologics and gene therapy,...
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Senior Director, Regulatory Affairs
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(Associate) Director, Regulatory Affairs CMC
2 weeks ago
London, United Kingdom Autolus Limited Full time £150 - £200(Associate) Director, Regulatory Affairs CMC page is loaded## (Associate) Director, Regulatory Affairs CMClocations: UKIncrease your chances of an interview by reading the following overview of this role before making an application.- London, White City: UK- Stevenagetime type: Full timeposted on: Posted Todaytime left to apply: End Date: January 5, 2026...
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Greater London, United Kingdom Beacon Therapeutics (USA) Inc Full timeA leading biotechnology firm is seeking a Full-Time Senior Director of Regulatory Affairs in the UK to provide essential regulatory leadership for innovative pipeline products. You will lead the EU & UK Marketing Authorization Application filing, guide teams on filing strategies, and leverage your deep regulatory expertise in a supportive, collaborative...
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(Associate) Director, Regulatory Affairs CMC
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