Senior Director/Executive Director, Regulatory Scientist, Global Regulatory Affairs, Asia-Pacific Region

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.Job Description:The purpose of the Senior Director/Executive Director, Regulatory Scientist role is to provide leadership and oversight to deliver Asia Pacific (AP) regulatory strategies and Win Through Regulatory for assigned assets.  The Regulatory Scientist will have therapeutic area alignment and partner across Lilly teams, partner companies, and health authorities to enable market differentiation of first-in-class/best-in-class assets. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.1. Regulatory and Scientific ExpertiseDevelop, Update and Execute Asia-Pacific Registration StrategyInitiate and Update Regulatory Strategy DocumentInitiate and update regulatory strategy documents by leveraging scientific, drug/device clinical development and knowledge from AP regulatory agency meetings and regulatory trends. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies.Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by Lilly and knowledge of competitor labelling.Monitor upcoming and recent approvals of competitive development programs/plansIntegrate AP regional regulatory strategy into global registration strategyServe as global regulatory coordinator as assigned by GRA management.Partner with colleagues across regulatory functions, particularly the global regulatory lead of the assigned molecules, to deliver integrated AP regulatory strategyCommunicate and share key information to enable seamless execution of AP regulatory strategyProvide input to clinical program to support market differentiation needsCommunicate the regulatory options and impact on proposed product development plans.Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets.Collaborate with Pricing Reimbursement and Access (PRA) and Value Evidence Outcome(VEO) for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planningLead development and update of labeling strategy to deliver market differentiationInitiate and update Claims Mapping and Labeling DashboardPartner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g. Claims mapping) and network for alignment.  Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments.  Use global labelling strategy to influence the drug development strategy, as needed.Create and communicate labeling dashboard to drive internal alignment on labeling strategy and key risks.Partner with Affiliate GRA teams to develop and Update local labeling, including prescribing information, patient labeling, device labeling (IFU) for new products and indicationsLead the development of the labelling strategy in collaboration with other regulatory and project personnel and network for alignment across affiliate labelling team to enable timely completion of regional product (drug and device) registration milestones (submission, approval and launch).Lead strategic development of regional labelling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and provide responses to agency labelling questions. Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling.Lead and develop the strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, and de novoDetermine and communicate submission and approval requirements and regulator expectationsGenerate regulatory documents for medium to high complexity submissions.  Ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate Lilly’s scientific position.Anticipate, resolve, and communicate key technical, operational, and strategic issues that may impact other development functions or the development team.Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems.Primary liaison with product and clinical development team and liaison with diagnostic development expertsProvide high quality, timely and decisive regulatory advice that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business developmentCommunicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory managementCultivate relationships with development teams and leadership.Liaison with global marketing/New Pr