SENIOR ASSOCIATE, EARLY PHASE, REGULATORY AFFAIRS

Job Summary Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-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 timely submissions and approvals in the EU region. Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio within the EU. Job Responsibilities Accountable for ensuring EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned early-stage oncology portfolio. Ensures regulatory contributions achieve the objectives in the strategy, meet agreed standards, maximize overall project delivery time and probability of success, and facilitate submission activities. Partners with project teams to ensure required regulatory contributions (CTA, etc.) meet business needs and are provided to the project teams, to agreed time and quality standards. Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management, and any risks mitigated. Ensures an aligned EU regulatory position is reached and communicated for all key issues for assigned project/s, and champions these regulatory positions supporting the EU business. Engages in appropriate activities to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate. Ensures business compliance and implementation of and adherence to Regulatory standards. Develops and maintains constructive working relationships with Health Authority contacts in the EU region. Organizational Relationship Reports to early phase Oncology EU lead. Works with GRS colleagues and relevant project team(s) members (i.e. Clinical and Project Management, Development Operations, Global Regulatory Sciences, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal). Partners with EU colleagues, including GRS-in Country colleagues and Medical colleagues, to provide an EU position. Works directly or indirectly with external contacts in Regulatory Agencies within EU region. Ensures alignment with GRL and early phase Oncology Global Head. Qualification Skills Scientific Degree. A higher degree may be an advantage but is not essential. Proven experience in managing national and/or EU regulatory processes and registration aspects of the drug development process, particularly clinical trials experience at least in one country. Previous experience as a national and/or EU regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable. Equivalent experience, either at a regulatory agency or working on substantive industry-government collaborations, can be considered. Experience in communicating with major EU regulatory agency(ies) respectively, as well as participating in/leading such interactions, is preferred. Knowledge of drug development practice rules, regulations, and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines. Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting CTAs. Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management. Presentation skills - Effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports, and senior management. Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations. #J-18808-Ljbffr