Responsibilities: Global Regulatory Strategy Lead (GRTL), Oncology will have leadership responsibility for global regulatory strategy for nivolumab/iplilimuab within a full development team (FDT). The GRTL will serve as team lead or co-lead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.
Details of The Global Regulatory Role Include:
Lead/Participate in Global Regulatory Teams (GRTs) Provide leadership to the global regulatory teams on critical project issues. Establish one regulatory voice and communicate same to key stakeholders. Develop registration strategy for a product. Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies. Develop strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions)
Propose innovative approaches to resolve complex regulatory issues and increase speed to patients.
Represent GRS on Early Development, Full Development and World Wide Brand teams and to governance committees.
Prepare content for regulatory strategic documentation and Regulatory Project Reviews Align regulatory plans with commercial and development plans.
Assure priority market and non-priority market regulatory issues are addressed in development plans. Assure CMC-components of overall global regulatory plan are robust.
Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, etc.
Review and approve key regulatory documents, including IB, IND, IMPDs, CTAs, RMP, Pediatric plans etc.
Facilitate identification and internal agreement of optimal labeling.
Provide strategic input on Target Product Profile, CCDS and country-specific labels Support effective interactions with HA globally Create an asset specific global HA interactions strategy, integrating regional/local objectives and strategies.
Support the preparation of, and participate in / lead (as appropriate), key HA interactions. Assure consistent positions on common issues are presented to global HA. Review and approve content of responses to queries from HAs for respective regions/countries.
Drive the creation and execution of the global submission plan. Formulate integrated global submission plan for simultaneous filings and communicate rationale for deviation from simultaneous submissions.
Qualifications
Background and Experience:
Solid scientific background, Ph.D., M.D., PharmD, MS, or BS with equivalent professional experience. Understanding of scientific content and complexities. A good knowledge of Oncology drug development is desired. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process. Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval.
Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.
Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.
Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
Experience as a member of GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).
Experience utilizing leadership techniques to drive a team through the stages of team development.
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