Associate Director, Regulatory Affairs
Found in: Talent UK C2 - 1 week ago
The Opportunity:
We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the global regulatory lead on relevant project teams to formulate and execute development strategies for developmental programs. You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions. You will be coaching and mentoring junior regulatory staff to support their development and enable program deliverables.
Your Role:
You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products. You will be responsible for leading the preparation and submission of high quality domestic and global regulatory submission documents (i.e. IND, CTA, NDA/MAA), as well as leading the development of response strategies to regulators. You will be responsible for communicating with the global regulatory authorities and leading the preparation and conduct of meetings with health authorities, which includes the development of robust briefing packages and comprehensive meeting preparation to maximize outcomes of meetings. You will be responsible for integrating your knowledge of current legislation, guidelines and other regulatory intelligence into the development strategies and ensuring compliance with regulatory filing and reporting requirements. You will be responsible for proactively identifying regulatory opportunities and risks and proposing alternative approaches and mitigations to resolve development program challenges. You will lead the efforts to plan and obtain regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations and contribute to the CDx strategy development and submissions. You will provide oversight to the global regulatory activities that are performed by our Clinical Research Organization (CROs) and regulatory vendors. You will lead and mentor junior staff in the regulatory team to support their development and enable program deliverables.Your Background:
You have earned your B.S and/or M.S. and bring at least 5 years of increasing responsibility in regulatory affairs. Advanced degree or education in a scientific field is a plus. You are results-oriented and have comprehensive knowledge of the drug development process and have a demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc.) Experience in precision oncology, rare disease and/or companion diagnostic (CDx) is a plus. You are a regulatory interpreter; you have experience in interpretation of regulations, guidelines, and policy statements and know how best to exercise regulatory flexibility. You are a strategic thinker, capable of proposing innovative solutions to regulatory problems. You have strong verbal and written communication skills, including the ability to present strategic topics/issues to project teams, management and regulatory agencies. Self-motivated and driven with a proactive and flexible working style with a passion for impacting patient's lives through regulatory work.#JO1
-
Associate Director
Found in: Talent UK C2 - 1 week ago
Cambridge, United Kingdom Gilead Sciences International, Ltd. Full timeDescription Regulatory Affairs Associate Director Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. Together we deliver life-saving therapies to patients in need. With...
-
Associate Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeAssociate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 5 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a...
-
Associate Regulatory Affairs Director
1 week ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeGlobal Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) Bewerben locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Vor 2 Tagen ausgeschrieben job requisition id R0040717 For Current Gilead Employees and Contractors: For more than 35 years,...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeGlobal Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) Bewerben locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Vor 2 Tagen ausgeschrieben job requisition id R0040717 For Current Gilead Employees and Contractors: Please log onto your...
-
Global Regulatory Affairs, Associate Director
Found in: Talent UK C2 - 2 weeks ago
Cambridge, United Kingdom Gilead Sciences International, Ltd. Full timeDescription We are looking for a driven individual who is passionate about bringing transformational medicines to those in Europe and international countries with continued unmet medical need. This is an exciting opportunity for a Regulatory Affairs Associate Director to join the Gilead Global Regulatory Affairs Oncology team to support drug...
-
Regulatory Affairs Specialist
2 weeks ago
Cambridge, United Kingdom Vector Recruitment Limited Full timeRegulatory Affairs Specialist £45k-£55k (dep on exp) Cambridge We have a brand-new vacancy for a Regulatory Affairs Specialist to join a fascinating Cambridge based R&D technology company. This business is very well established and is undergoing rapid growth due to the impact that their market disruptive technology is having on the medical...
-
Regulatory Affairs Program Director M/F
Found in: Talent UK C2 - 1 week ago
Cambridge, United Kingdom ProductLife Group Full timeRegulatory Affairs Program Director M/F - 080 Our RA teams are looking for a Program Director based in the UK to pilot and manage Regulatory Affairs outsourcing projects/programs for major clients for which specific dedicated programs and teams are put in place. About us Group 10 Missions You will act as a direct point of contact with...
-
Director of Policy and Regulatory Affairs
2 days ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeLabelling, Artwork & Translations – Regulatory Manager page is loaded Labelling, Artwork & Translations – Regulatory Manager Bewerben locations United Kingdom - Cambridge time type Full time posted on Vor 5 Tagen ausgeschrieben job requisition id R0040537 For Current Gilead Employees and Contractors: For more than 35 years, we’ve tackled diseases...
-
Regulatory Project Manager
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Hays Full timeRegulatory Affairs Labelling Associate Project Manager contract job This well-known biopharmaceutical company is looking for a Regulatory Affairs Labelling Associate Project Manager to join their Labelling team on a contracting basis. This is a 12-month contract job with scope for extension and is fully remote. As part of the Global Labelling Strategy...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeSenior Manager Regulatory Affairs Vendor Governance page is loaded Senior Manager Regulatory Affairs Vendor Governance Apply locations United Kingdom - Cambridge time type Full time posted on Posted 6 Days Ago job requisition id R0040568 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At...
-
Regulatory Affairs Specialist Us Market
2 weeks ago
Cambridge, United Kingdom Vector Recruitment Limited Full timeRegulatory Affairs Specialist - US Market £45k-£55k (dep on exp) Cambridge We have a brand-new vacancy for a Regulatory Affairs Specialist to join a fascinating Cambridge based R&D technology company. This business is very well established and is undergoing rapid growth due to the impact that their market disruptive technology is having on the medical...
-
Senior Manager, Regulatory Affairs
Found in: Talent UK C2 - 2 days ago
Cambridge, United Kingdom Relay Therapeutics Full timeThe Opportunity: We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to help define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the regulatory representative on relevant project teams...
-
Senior QA
2 weeks ago
Cambridge, United Kingdom Vector Recruitment Limited Full timeSenior Quality Assurance & Regulatory Affairs Specialist Cambridge £45k-£55k (dep on exp) plus bonus and excellent benefits We are looking for a Senior QA & Regulatory Affairs Specialist with excellent academics and experience within a variety of different industries - a mixture of Medical and non-medical. You will be joining a high calibre,...
-
Regulatory Affairs Executive
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom AstraZeneca UK Full timeJoin a place built on innovation and creativity. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s...
-
Regulatory Affairs Consultant for Nutrition and Health Products M/F
Found in: Talent UK C2 - 1 week ago
Cambridge, United Kingdom ProductLife Group Full timeAbout the job To strengthen our regulatory affairs division in the UK and Europe, RNI (a ProductLife Group Company) is urgently looking for a Regulatory Affairs Consultant with experience working on nutrition & health products in the UK and Europe. About us Group 10 Responsibilities The candidate will have 7+ years’ experience in...
-
Senior Manager Regulatory Affairs Vendor Governance
Found in: Talent UK C2 - 2 weeks ago
Cambridge, United Kingdom Gilead Sciences International, Ltd. Full timeDescription Regulatory Affairs Vendor Governance is a function within the RA Business Operations group supporting all of Gilead RA’s subfunctions. Vendor Governance is responsible for the selection, implementation, governance, relationship management, tracking, and overall success of the vendor partnerships utilized by Regulatory Affairs. Gilead...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeSenior Manager Regulatory Affairs Vendor Governance page is loaded Senior Manager Regulatory Affairs Vendor Governance Bewerben locations United Kingdom - Cambridge time type Full time posted on Vor 2 Tagen ausgeschrieben job requisition id R0040568 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this...
-
Regulatory Project Coordinator
Found in: Appcast UK C2 - 1 day ago
Cambridge, United Kingdom Park Street People Full timeOur client, a global pharmaceutical company, is currently looking for a Project Coordinator – Labelling to join their team, this is a great opportunity to build on your project management and regulatory affairs experience.You will be working for a global pharmaceutical company who have created a centre of excellence and constantly focus on driving...
-
Regulatory Project Coordinator
Found in: Whatjobs ES C2 - 22 hours ago
Cambridge, United Kingdom Park Street People Full timeOur client, a global pharmaceutical company, is currently looking for a Project Coordinator – Labelling to join their team, this is a great opportunity to build on your project management and regulatory affairs experience. You will be working for a global pharmaceutical company who have created a centre of excellence and constantly focus on driving...
-
Regulatory Project Coordinator
Found in: Appcast Linkedin GBL C2 - 2 days ago
Cambridge, United Kingdom Park Street People Full timeOur client, a global pharmaceutical company, is currently looking for a Project Coordinator – Labelling to join their team, this is a great opportunity to build on your project management and regulatory affairs experience.You will be working for a global pharmaceutical company who have created a centre of excellence and constantly focus on driving...