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Global Regulatory Affairs Lead

St. Giles, Devon
Job Type
22 Sep 2022
As a Global Regulatory Lead, you will contribute to development (from pre-clinical through clinical studies to initial registration in key global markets) of radiopharmaceutical diagnostics, including 'tracers' targeting biomarkers of neurodegenerative diseases, cardiac function and oncology tumour expression. You will be 'the face' of the Global Regulatory function on cross-functional global project teams for new product introductions and single point of accountability for Global Regulatory Strategy Leadership and policy development. Job Description Responsibilities Develop global (including US, EU, China and Japan) innovative regulatory strategies for assigned projects and lead their implementation. Serve as the primary interface for key health authorities, such as FDA and EMA, on assigned projects, leading interactions and meetings with these authorities. Lead preparation of briefing documents for regulatory authority meetings, including team rehearsals, slides and minutes. Provide strategic regulatory advice to optimise product development and speed to market (e.g., Fast Track and Breakthrough Designations, PRIME, Orphan Drug Designation, PIP/PSP). Deliver competitive submission strategies, enabling successful NDA and MAA filings and guide cross-functional global project teams for the content and preparation of submissions. Lead marketing authorisation application submissions in key markets such as US and EU, coordinate and prepare responses to related questions from regulatory authorities. Review and contribute to submissions during development, such as INDs/CTAs, Clinical Study Protocols, IBs, DSURs and other documents of regulatory relevance. Represent Regulatory Affairs on cross-functional global project teams and internal/external meetings. Work closely with cross-functional teams to timely execute project related activities and regulatory submissions. Perform regulatory due diligence assessments for new opportunities. Build effective business focused strategic partnerships with a wide range of functions including colleagues in R&D, Commercial, Project Management, Supply Chain, Pharmacovigilance and Quality Assurance functions, demonstrating that Regulatory Affairs is a full partner in supporting GEHC strategic aims. Qualifications and Experience Bachelor's degree (or equivalent) in a scientific discipline; post-graduate degree preferred. Maintaining a keen interest in scientific advances that impact healthcare product development and regulation. Substantial experience of global regulatory affairs from the pharmaceutical and/or healthcare industry with a track record in key strategic roles. May have skills and knowledge in specialised areas key to specific business need, for example registration of oncology/ immuno-oncology products or biologics. Experience of regulatory submissions and approvals in key regions such as EU, US and APAC, including new MAAs/NDAs. Significant experience of global regulatory project management and world-wide regulatory authority interactions. Experience of working with business leadership to define high level strategies. Experience of working effectively across multinational/cultural environments. Eligibility requirements A good level of English and a valid work permit Inclusion and Diversity GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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  • Job Reference: 718772477-2
  • Date Posted: 22 September 2022
  • Recruiter: GE Healthcare
  • Location: St. Giles, Devon
  • Salary: On Application
  • Sector: Government & Defence
  • Job Type: Permanent
  • Start Date: Fri, 16 Sep 2022 11:14:00 EST