Eli Lilly and Company

Senior Director – Global Regulatory Lead, Oncology

Eli Lilly and Company

full-time

Posted on:

Location Type: Remote

Location: California • Connecticut • United States

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Salary

💰 $169,500 - $248,600 per year

Job Level

Senior

About the role

  • 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.

Requirements

  • Advanced scientific degree (i.e., PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR Bachelor’s degree with 10+ years of industry-related experience in regulatory affairs and/or drug development experience
  • Proven experiences and leadership assignments demonstrating bold leadership, exemplary team attributes, effective communications with peers and executive leaders, and effective conflict management skills
  • Travel expected (10-15%)
  • Experience in regulatory submissions and regulatory interactions in the US, EU, China and Japan
  • Previous regulatory or leadership assignments across multiple countries
  • Industry-related experience in regulatory affairs and/or drug development experience for 10 years
  • Direct experience in clinical and CMC regulatory sciences
  • Experience in applicable therapeutic area
  • Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives
  • Demonstrated deep knowledge of the integrated drug development process and Lilly’s (or external peer company) regulatory/business strategies
  • Demonstrated ability to find solutions and alternatives through teamwork, resulting in positive business outcomes
  • Demonstrated ability to assess and manage risk in a highly regulated environment
  • Strong written, spoken and presentation communication
  • Demonstrated negotiation and influence skills
  • Demonstrated attention to detail.
Benefits
  • eligibility to participate in a company-sponsored 401(k)
  • pension
  • vacation benefits
  • eligibility for medical, dental, vision and prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance and death benefits
  • certain time off and leave of absence benefits
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategy developmentregulatory submissionsclinical regulatory sciencesCMC regulatory sciencesdrug developmentregulatory interactionsregulatory policiesregulatory precedentsregulatory guidancetherapeutic area knowledge
Soft Skills
bold leadershipeffective communicationconflict managementteamworkrisk assessmentnegotiation skillsinfluence skillsattention to detail
Certifications
PhDPharmD