Europe Regulatory Strategist Locations: United Kingdom - Sandwich, United Kingdom - Walton Oaks, Italy - Milan
Time Type: Full-time
Posted on: 9 days ago
Job Description: Europe Regulatory Strategist Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated late-stage oncology portfolio. Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST). Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the company goals. Accountable for managing the lifecycle of assigned products. Accountable for timely submissions and approvals. Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio. Job Responsibilities Accountable for ensuring contribution to Global Regulatory Strategies and implementation plans for assigned oncology portfolio. Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating filing activities. Responsible for providing strategic input into EU clinical trial submissions, including protocol and IB review and RFI management. Accountable for managing the product lifecycle of assigned products which includes:
Preparing and reviewing documentation and supporting materials to be submitted to the EMA including variations and renewal applications with minimal supervision. Maintaining the product information and associated artworks, and working closely with the supply teams to optimise any changes. Prepare applications for marketing authorisations in new markets (for existing and new products). Works cross-functionally with teams including labelling, CMC and submission management. Works with external regulatory partners. Communicates with and owns relationships with health authorities. Ensures business compliance and implementation of and adherence to Regulatory standards. Develops and maintains, directly or indirectly, constructive working relationships with Health Authority contacts in the assigned region. Qualification Skills Scientific Degree. A higher degree may be an advantage but is not essential. Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process, particularly clinical trials experience at least in one country. Experience preparing and submitting CTAs and MAAs. Experience of managing an MA post authorisation. Previous experience as a national and/or regional regulatory liaison for a product in different stages of its life cycle is highly desirable. Experience in communicating with a major EU regulatory agency. Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines. Working with and influencing regulators and facilitating approval of submissions. Ability to communicate complex information and analyses to a variety of stakeholders in both verbal and written format. Effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior management. Work Location Assignment: Walton Oaks or Sandwich (UK), or Milan (Italy) – flexible working arrangements possible.
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