Senior Director Global Regulatory Lead - Oncology

Primary Responsibilities

• Develop, Update and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)
  • Obtain input from the global regulatory team members to develop a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance globally.
    • Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecyle (including NILEX).
      • Develop and implement innovative approaches and solutions, and drive acceleration strategies.
        • Identify and effectively communicate regulatory risks.
          • Lead Global Regulatory Team in the development of RSD(s) for assigned programs.
            • Initiate and maintain regulatory strategy documents by leveraging team expertise, as well as scientific, drug/device clinical development and knowledge from health authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory science.
              • Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies and solutions.
                • Provide input for and attend key regulatory agency meetings, as needed, that could impact the global product strategy or brand.
                  • Enable discussion of the RSD and regulatory issues/challenges at the Regulatory Strategy Forum together with Global Regulatory Team.
                    • Continually expand therapeutic area knowledge.
                      • Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment.
                        • Monitor upcoming and recent approvals of competitive development programs/plans.
                          • Ensure strategic messaging and content of global regulatory submission documents.
                            • Provide regulatory direction in the development of the core data sheet and claims mapping to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent.
                              • Ensures local strategies and solution deliver to the global regulatory strategy and meets BU and brand goals.
                                • Provide timely and effective communication updates to the GBD teams and BU management and other internal stakeholders, as appropriate.