Senior/ Executive Director, Global Regulatory Strategy

Eli Lilly and Company; Boston (MA); Teletrabalho; USD 194 000 - 398 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Company bonus

401(k) plan

Comprehensive benefits

Resumo da oferta

The Senior/Executive Director, Global Regulatory Strategy at Lilly (Centessa Pharmaceuticals as part of Lilly) leads global regulatory programs, guiding strategy and submissions across regions. This role requires strong leadership, cross-functional collaboration, and direct interactions with major health authorities, including the FDA and EMA.

Remote US-based with occasional travel. As a senior regulatory leader, you will mentor staff, oversee external consultants, and drive regulatory

Qualificações

• 12+ years of progressive regulatory affairs experience in pharma/biotech.
• 5+ years in global regulatory leadership role preferred.
• Experience leading NDA strategy, submission, and reviews.
• Experience with NDA/IND/CTAs and global regulatory filings.

Responsabilidades

• Serve as Global Regulatory Lead for development programs from early development through registration and lifecycle management.
• Develop and execute global regulatory strategies across regions and health authorities.
• Lead planning, preparation, and submission of major regulatory filings (INDs, NDAs, briefing documents).
• Represent the company in regulatory interactions and lead meetings with FDA, EMA, and others.
• Provide regulatory guidance to cross-functional program teams and ensure alignment with development plans.

Conhecimentos

Regulatory leadership

NDA/IND submissions

FDA/EMA interactions

Cross-functional leadership

Regulatory strategy

Formação académica

Bachelor's degree in a scientific discipline

Advanced degree (PhD, PharmD, MS, or JD)

Descrição da oferta de emprego

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.

Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

Overview

As the Senior/ Executive Director, Global Regulatory Strategy you will report to the VP, Regulatory and Medical Writing and serve as a key member within our regulatory team, providing strategic and operational regulatory leadership across global development programs. As the Regulatory Lead for assigned assets, you will develop and execute global regulatory strategies spanning nonclinical, clinical, and registration activities, including leading NDA planning, preparation, and submission efforts. The role requires extensive experience leading global regulatory programs and managing interactions with health authorities, including the FDA and other international regulatory agencies. In partnership with cross-functional development teams, you will provide regulatory guidance, lead regulatory sub-teams, and align stakeholders to support successful program advancement from development through registration. This position also requires prior direct people management experience, success operating within a matrixed organization, and the ability to oversee external regulatory consultants and vendors while driving regulatory excellence across the portfolio.

Responsibilities

• Serve as the Global Regulatory Lead for assigned development programs, providing strategic regulatory leadership from early development through registration and lifecycle management.
• Develop and execute global regulatory strategies to obtain, maintain, and expand product registrations across multiple regions and health authorities.
• Lead the planning, preparation, and submission of major regulatory filings, including INDs, NDAs, briefing documents, and other regulatory submissions within scope of responsibility.
• Represent the company in regulatory interactions and lead meetings with global health authorities, including the FDA and other international regulatory agencies.
• Provide regulatory guidance and strategic input to cross-functional program teams, ensuring regulatory considerations are integrated into development plans and key business decisions.
• Lead regulatory sub-teams and represent Regulatory Affairs on cross-functional governance and program teams, driving alignment among internal stakeholders and senior leadership.
• Manage, develop, and mentor regulatory staff, fostering professional growth and building organizational capability within the Regulatory Affairs function.
• Ensure ongoing compliance with applicable regulatory requirements and guidance, communicating regulatory developments and implications to relevant stakeholders.
• Partner with the VP, Regulatory and Medical Writing and broader Regulatory Affairs leadership to strengthen departmental capabilities, operational excellence, and efficient execution across the portfolio.
• Identify, engage, and oversee external regulatory consultants and vendors to support the successful execution of regulatory strategies and submissions.

Requirements

• Bachelor's degree in a scientific discipline with 12+ years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry, including 5+ years in a global regulatory leadership role.
• Advanced degree (PhD, PharmD, MS, or JD) and experience supporting small molecule development strongly preferred.
• Experience in CNS strongly preferred.
• Significant NDA leadership experience, including direct responsibility for NDA strategy, submission, and regulatory review activities in a sponsor organization.
• Must have recent significant experience with regulatory submission strategy, structure, and content, including NDAs, INDs, CTAs, and other global regulatory filings.
• Demonstrated track record of successful regulatory interactions with the FDA, EMA, and other global health authorities supporting major submissions and product approvals.
• Proven success serving as the Global Regulatory Lead for development and registration-stage programs within a matrixed environment, including direct people management experience.
• Extensive knowledge of nonclinical and clinical drug development, FDA, ICH, EMA, EU National Competent Authority, MHRA, and other applicable global regulatory requirements and guidelines.
• Strong experience leading cross-functional teams and providing strategic regulatory guidance to development programs from early development through registration and lifecycle management.
• Excellent written, verbal, presentation, and influencing skills, with the ability to communicate complex regulatory strategies and risks to senior management, health authorities, consultants, and external partners.
• Proven analytical, problem-solving, organizational, negotiation, and decision-making skills, with the ability to develop regulatory strategies and compelling, data-driven regulatory narratives.
• Demonstrated ability to thrive in a fast-paced, innovative environment while fostering collaboration, open communication, and alignment among diverse stakeholders.

Work Location

The role is remote and based in the US, with occasional travel.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$193,500 - $398,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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