Europe Regulatory Strategist

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 own relationships with health authorities.
• Ensures business compliance and implementation of and adherence to Regulatory standards.
• Develops and maintains, directly or indirectly, constructive working relationship 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 MAA's.
• 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.
• Is 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.
Purpose
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Regulatory Affairs
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