Associate Director, Regulatory Affairs
2 weeks ago
Job Description SummaryYou could be just the right applicant for this job Read all associated information and make sure to apply.Office Location: London (The Westworks), United Kingdom#LI-Hybrid Hybrid (12 days per month on-site if living within 50 miles to our London office)#LI-Remote Remote (if living beyond 50 miles to our London office)The Associate Director, Regulatory Affairs (Medical Devices) independently provides strategic and operational global medical device regulatory direction and documentation for projects/products covering design and development, registration, approval and post approval activities.You will make informed, compliant regulatory decisions, balancing patient and business risks and benefits leading to timely Health Authority approvals.Major accountabilitiesDevelop and communicate RA MD regulatory strategies for projects across the life cycle (Development and On-Market).Ensure device regulatory risks and key issues are communicated in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams as appropriate.Provide Novartis technical functions clear, concise guidance on current device regulatory requirements to support planning and decision making.Lead and implement global Regulatory Affairs Medical Device (RA MD) submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.Identify the required documentation and content, compliance and timelines issues for global submissions and work collaboratively with cross-functional teams for the delivery of technical source documents in accordance with project timelines.Author and/or review compliant RA MD documentation for HA submissions, applying agreed RA MD Global regulatory strategies, current regulatory standards and guidelines.Lead, prepare and communicate RA MD risk management assessments, contingency plans, and lessons learned on major submissions and elevate as appropriate.Facilitate/support device related interactions with Health Authorities globally.Contribute to knowledge sharing, e.g. provide coaching within RA CMC and other functional areas.Contribute to the development of new guidance, policy, and processes.Minimum RequirementsExperience in Medical Device Regulatory Affairs.Significant experience in the combination product or medical device industry.Proven knowledge of regulatory submission and approval processes for medical devices and combination products.Ability to critically evaluate data across diverse scientific disciplines.Understanding of product development and lifecycle management.Demonstrated success in leading and prioritizing multiple projects in global, cross-functional teams.Strong independent working skills with the ability to manage timelines and workload effectively.Excellent planning, organizational, and interpersonal skills.Proficiency in computer and IT systems.Commitment to Diversity & InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse team’s representation of the patients and communities we serve.Skills DesiredClinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management#J-18808-Ljbffr
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Director of Regulatory Affairs
3 weeks ago
london, United Kingdom VRS Regulatory Full timeA unique opportunity to take a key role on the leadership team of a highly successful and award-winning developer of naturally sourced, sustainable ingredients for regulated consumer products. They are the leader in their field, the market is exploding, this position will be paramount to this regulatory centric business’ continued global growth. The...
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(Associate) Director, Regulatory Affairs CMC
6 days 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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(Associate) Director, Regulatory Affairs CMC
3 days ago
City Of London, United Kingdom Autolus Limited Full time(Associate) Director, Regulatory Affairs CMC page is loaded## (Associate) Director, Regulatory Affairs CMClocations: UK - London, White City: UK - Stevenagetime type: Full timeposted on: Posted Todaytime left to apply: End Date: January 5, 2026 (30+ days left to apply)job requisition id: JR100066**Work with us** Our team are passionate in the...
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Associate Director, Regulatory Affairs
6 days ago
London, United Kingdom Shionogi Europe Full time £150 - £200This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.Increase your chances of an interview by reading the following overview of this role before making an application.DescriptionShape the Future of Regulatory Excellence with ShionogiAt Shionogi, we are dedicated to protecting the health and well-being of people...
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Associate Director, Regulatory Affairs
3 days ago
London, Greater London, United Kingdom Shionogi Europe Full time £80,000 - £120,000 per yearDescriptionShape the Future of Regulatory Excellence with ShionogiAt Shionogi, we are dedicated to protecting the health and well-being of people worldwide. As a global pharmaceutical leader, we are driven by science, innovation, and a deep sense of responsibility to public health. Join us in our mission to deliver life-changing treatments by ensuring robust...
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London, United Kingdom MSD Full timeWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...
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Global Regulatory Affairs Associate Director
6 days ago
London, United Kingdom Novartis Full time £150 - £200Global Regulatory Affairs Associate Director (Cardio‑Metabolic)Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.Join us to apply for the Global Regulatory Affairs Associate Director (Cardio‑Metabolic) role at Novartis.Office LocationLondon (The Westworks), United Kingdom. Hybrid: 12 days...
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Associate Director Regulatory Affairs
3 weeks ago
london (city of london), United Kingdom Cpl Life Sciences Full timeTitle: Global Associate Director, Regulatory Affairs Job Type: Full-time permanent position Location: West London, UK – 3x a week in the office Salary: £90,000 - £100,000 + Car Allowance + Bonus Working for one of the industry’s leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge from pre-clinical...
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Associate Director, Regulatory Affairs
2 weeks ago
London, Greater London, United Kingdom Novartis Full time £80,000 - £120,000 per yearJob Description Summary#LI-Hybrid (12 days per month on-site)Location: London (The Westworks), United KingdomThe Associate Director, Regulatory Affairs (Medical Devices) independently provides strategic and operational global medical device regulatory direction and documentation for projects/products covering design and development, registration, approval...
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Global Regulatory Affairs Associate Director
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London (The Westworks), United Kingdom Novartis Full time £80,000 - £120,000 per yearJob Description SummaryOffice Location: London (The Westworks), United Kingdom #LI-Hybrid Hybrid (12 days per month on-site if living within 50 miles to our London office)#LI-Remote Remote (if living beyond 50 miles to our London office)Internal Job Title: Global Program Regulatory Associate DirectorWe are looking for an experienced and proactive Global...
