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    Senior Director - Explor&D Global Regulatory Affairs

    Eli Lily
    5+ years
    Not Disclosed
    Indianapolis
    10 Jan. 31, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Director - ExploR&D Global Regulatory Affairs
    Location: Indianapolis, Indiana, United States (Flexible global locations with preference for London, UK; Indianapolis, IN; Boston, MA; or San Francisco, CA)
    Category: Research & Development
    Job Type: Full-Time, Regular
    Job ID: R-75627

    About Lilly:

    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, with employees dedicated to discovering and bringing life-changing medicines to those in need, improving disease management, and giving back to our communities. We give our best effort in our work and put people first. We’re looking for individuals who are determined to make life better for people worldwide.

    Position Summary:

    The Senior Director - ExploR&D Global Regulatory Affairs will play a key role in managing all regulatory activities for assigned programs across various therapeutic areas and geographies, with a focus on the US, UK, EU, and Canada. You will lead a multidisciplinary team to construct and implement strategies for molecule development, helping drive decisions that mitigate risks related to safety and efficacy.

    This role is vital in ensuring regulatory strategies align with global guidelines and innovative development pathways. You will advise on IND/CTA submissions, expedited pathways, orphan drug designation, and more, enabling successful molecule progression through development.

    Key Responsibilities:

    • Global Regulatory Strategy: Provide regulatory leadership and guidance on global strategies for development programs across multiple regions, including the US, EU, UK, and Canada.
    • Regulatory Submissions: Advise on the content and preparation of regulatory submissions such as IND/CTA filings, clinical protocols, IMPD, nonclinical, and clinical summaries, ensuring compliance with regulatory guidelines.
    • Leadership in Drug Development: Lead regulatory activities for first-in-human clinical trials through clinical proof of concept. Develop adaptive regulatory strategies to enable seamless transitions once proof of concept is established.
    • Cross-functional Collaboration: Collaborate with internal teams and external partners, including CROs, to ensure regulatory timelines and quality are maintained.
    • Risk Assessment & Mitigation: Provide insights on regulatory risks, mitigation plans, and contingencies to inform key decision-making.
    • External Partner Management: Lead and manage relationships with regulatory agencies and third-party vendors. Ensure milestones are met on time, within budget, and within scope.
    • Innovation in Regulatory Affairs: Advise on infrastructure, IT solutions, and the implementation of artificial intelligence tools to enhance regulatory processes.
    • Due Diligence: Conduct regulatory due diligence for incoming assets and provide expertise to support the evaluation of new projects.

    Basic Qualifications:

    • Advanced graduate degree (MS, PharmD, PhD, MD) in a health-related or scientific field (e.g., life sciences, chemistry, pharmacy) from an accredited institution.
    • A minimum of 5 years of experience in regulatory affairs, with a focus on research-based drug development and first-in-human submissions.
    • In-depth understanding of global regulatory frameworks (US, UK, EU, Canada).
    • Proven track record of managing regulatory affairs for early-phase drug development and clinical trials.
    • Skilled at managing relationships with external partners, including CROs, regulatory agencies, and vendors.

    Additional Skills and Preferences:

    • Leadership & Strategic Thinking: Ability to demonstrate entrepreneurial mindset, strategic thinking, and teamwork.
    • Communication: Strong interpersonal and communication skills, with the ability to influence and connect with stakeholders at various levels both internally and externally.
    • Global Collaboration: Experience working with cross-functional teams across multiple therapeutic areas and regions.
    • Cultural Competency: Openness to diverse work styles and cultural differences.
    • AI Integration: Experience in implementing artificial intelligence tools in regulatory processes is a plus.
    • Negotiation & Organizational Skills: Strong negotiation and organizational skills to manage multiple priorities and ensure timely project completion.

    Additional Information:

    • This role reports to the Associate Vice President, ExploR&D, Regulatory Affairs, Medical Writing, and Quality.
    • Full-time equivalent employees will be eligible for a company bonus based on company and individual performance.
    • Lilly offers a comprehensive benefits package including medical, dental, vision, 401(k), pension, and other well-being benefits.

    Equal Opportunity Employer:

    Lilly is an Equal Opportunity Employer (EEO) and Affirmative Action Employer, committed to building an inclusive, diverse workforce. We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

     

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