Associate Director, Regulatory Project Management

BioSpace; Indianapolis (IN); Remote; USD 137,000 - 220,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Flexible benefits

Life insurance

Well-being benefits

Job summary

Lilly is seeking an Associate Director, Regulatory Project Management for a remote US‑based role with occasional travel. You will lead regulatory submission planning, cross‑functional coordination, and risk management to ensure on‑time IND/NDA submissions and post‑approval activities.

The role emphasizes strong communication with global health authorities, budget oversight, and collaboration with Clinical, Nonclinical, CMC, Quality, and Commercial teams to deliver compliant strategies that

Qualifications

• Bachelor’s degree in a scientific or related field.
• 8+ years of industry based regulatory experience.
• Strong understanding of regulatory frameworks and compliance requirements in relevant industries.
• Proficiency in project management tools (e.g., Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC) for planning, tracking, and reporting.
• Excellent interpersonal and communication skills to engage stakeholders, facilitate meetings, and drive decision‑making.

Responsibilities

• Project Planning and Execution: Develop and maintain integrated project plans for regulatory submissions (e.g., IND, NDA, BLA, MAA) and post‑approval activities, ensuring adherence to scope, timelines, budgets, and quality standard
• Cross‑Functional Coordination: Act as the primary regulatory contact for timelines from functions including Clinical, Nonclinical, CMC, Quality, and Commercial, fostering collaboration and alignment
• Risk Management: Identify, assess, and mitigate project risks, creating contingency plans to maintain compliance and meet milestones
• Regulatory Communication: Coordinate with Regulatory Strategy Lead to manage interactions with global health authorities, prepare teams for agency meetings, and lead responses to regulatory queries
• Documentation Oversight: Coordinate the authoring, review, and assembly of submission‑ready regulatory dossiers, ensuring accuracy and consistency
• Budget and Resource Management: Develop and track project budgets, forecast expenditures, and report financial performance to leadership

Skills

Regulatory project management

Cross-functional coordination

Risk management

Communication with regulatory bodies

Budget and resource management

Education

Bachelor's degree in a scientific or related field

Tools

Microsoft Project

Smartsheet

Job description

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.

Overview

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.

Responsibilities

• Project Planning and Execution: Develop and maintain integrated project plans for regulatory submissions (e.g., IND, NDA, BLA, MAA) and post‑approval activities, ensuring adherence to scope, timelines, budgets, and quality standard
• Cross‑Functional Coordination: Act as the primary regulatory contact for timelines from functions including Clinical, Nonclinical, CMC, Quality, and Commercial, fostering collaboration and alignment
• Risk Management: Identify, assess, and mitigate project risks, creating contingency plans to maintain compliance and meet milestones
• Regulatory Communication: Coordinate with Regulatory Strategy Lead to manage interactions with global health authorities, prepare teams for agency meetings, and lead responses to regulatory queries
• Documentation Oversight: Coordinate the authoring, review, and assembly of submission‑ready regulatory dossiers, ensuring accuracy and consistency
• Budget and Resource Management: Develop and track project budgets, forecast expenditures, and report financial performance to leadership

Basic Qualifications

RPMs require a blend of regulatory knowledge and project management expertise.

• Bachelor’s degree in a scientific or related field
• 8+ years of industry based regulatory experience
• Strong understanding of regulatory frameworks and compliance requirements in relevant industries
• Proficiency in project management tools (e.g., Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC) for planning, tracking, and reporting
• Excellent interpersonal and communication skills to engage stakeholders, facilitate meetings, and drive decision‑making
• Communication skills are crucial for interacting with regulatory bodies, internal management, and cross‑functional teams, facilitating collaboration and maintaining project alignment
• Analytical and problem‑solving abilities to interpret regulatory requirements and translate them into actionable project tasks
• Attention to detail is important for preparing accurate documentation and maintaining regulatory compliance

Work Location

The Associate Director, Regulatory Project Management role is a remote position 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

$136,500 - $220,000

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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