Senior Director, Global Regulatory Lead – Oncology

🕒 Yesterday

🏄 California, Connecticut – Remote

🏄 California – Remote 🦌 Connecticut – Remote

💵 $169.5k - $248.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1876

💊 Pharmaceuticals

Pharmaceuticals

Eli Lilly and Company is a pharmaceutical company that engages in the discovery, development, and marketing of products in the pharmaceutical industry. The company's mission is to make life better for people around the world by discovering, developing, and delivering innovative human medicines.

📋 Description

• The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. • The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of life cycle to ensure strategies meet global business objectives and regional/local affiliate requirements. • The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists) and is responsible for forming and maintaining a highly effective global regulatory team. • The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional regulatory teams, are aligned to the Global Brand Development (GBD)/global program team and business priorities. • For preclinical and early clinical development programs, the GRL leads the US submissions and agency interactions. • Ensure strategic messaging and content of global regulatory submission documents. • Provide timely and effective communication updates to the GBD teams and BU management and other internal stakeholders, as appropriate. • Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment.

🎯 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)