Associate Director, Regulatory Starting Material

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 126,000 - 268,000; Full time

Benefits offered by this job

Bonus program

401(k) plan

Medical/dental/vision insurance

Vacation benefits

Well-being program

Job summary

Lilly in the US is seeking an Associate Director, Regulatory Starting Material to lead strategy, justification, and regulatory positioning of RSM for drug substance manufacturing supporting late-stage programs. You will partner with multiple functions to ensure scientifically sound and regulatorily defensible material design and readiness for commercial manufacturing.

The role requires PhD preferred and 7+ years in CMC or drug substance development with strong writing and leadership skills.

Qualifications

• Experience leading regulatory strategy for drug substance starting materials.
• Authoring and defending CMC regulatory submissions and health authority interactions.
• Deep knowledge of ICH Q11 and regional guidance for starting materials.
• Leadership of cross-functional teams in late-stage programs.
• Experience with CMOs and supplier management.
• Strong technical writing and communication skills.

Responsibilities

• Lead regulatory strategy for Regulatory Starting Materials across routes.
• Manage resupply, scale-up, inventory, and scheduling with CMOs.
• Prepare and defend CMC submissions (Module 3, briefing docs, responses).
• Lead health authority meetings and prepare briefing packages.
• Collaborate with Process Chemistry, Analytical Development, Regulatory Affairs, QA.
• Define GMP/non-GMP boundaries for drug substance processes.
• Oversee technology transfer and changes affecting RSM designation.
• Manage relationships with CMOs and RSM suppliers.
• Monitor regulatory guidance and update internal templates and risk assessments.
• Support cross-functional program timelines and supply continuity.

Education

PhD preferred

Advanced degree in chemistry/related field

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.

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation.Our asset‑centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation.Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset‑centric model can lead to improved success rates for programs with greater speed and modest costs.

Centessa is currently seeking an Associate Director, Regulatory Starting Material. This individual will lead the strategy, justification, and regulatory positioning of Regulatory Starting Materials for drug substance manufacturing processes supporting late‑stage clinical and commercial programs. Reporting to the Vice President, CMC, this role will serve as the internal and external subject matter expert on RSM selection in accordance with ICH Q11 and applicable regional guidance, ensuring synthetic routes, GMP starting points, and supply strategies are scientifically sound, regulatorily defensi A ble, and aligned with commercial manufacturing readiness. This individual will partner closely with Process Chemistry, Analytical Development, Regulatory Affairs, Quality, and external manufacturing partners to build and defend RSM strategy through health authority interactions and regulatory submissions.

Responsibilities:

• Lead the identification, justification, and regulatory strategy for Regulatory Starting Materials across drug substance synthetic routes, in accordance with ICH Q11 and relevant regional guidance/reflection papers.

• Actively manage the starting material resupply campaigns and scale‑up efforts, including on‑going inventory, production forecast, manufacturing timing, production suite slot reservations, and contracting.

• Author and review CMC regulatory submission content related to RSM selection and justification (e.g., Module 3 sections, briefing documents, agency responses) in support of INDs/NDAs /MAAs.

• Prepare and lead health authority interactions (e.g., Type C meetings, scientific advice procedures) related to starting material strategy; develop briefing packages and represent the company in agency discussions.

• Partner with Process Chemistry and Analytical Development to evaluate synthetic routes, assess structural relevance of candidate starting materials, and support impurity fate‑and‑purge and risk assessments that inform RSM designation.

• Define and document the boundary between non‑GMP and GMP manufacturing steps for drug substance processes, ensuring alignment with CMOs and internal quality standards.

• Lead technology transfer and process changes affecting RSM designation as programs advance from late‑stage clinical development toward commercial manufacturing.

• Manage relationships with drug substance/API CMOs and RSM suppliers, including technical oversight, site visits, and support for supplier qualification and dual‑sourcing strategies.

• Monitor evolving global regulatory guidance and agency precedent on starting material selection; translate changes into updated internal strategy, templates, and risk assessments.

• Collaborate cross‑functionally with Regulatory Affairs, Quality, Supply Chain, and Manufacturing to ensure RSM strategy supports program timelines, submission readiness, and commercial supply continuity.

• Support due diligence activities (e.g., licensing, partnering) requiring assessment of drug substance manufacturing routes and starting material risk.

• Provide subject matter expertise during regulatory inspections and audits related to drug substance manufacturing and starting material justification.

• Build, lead, and mentor a team supporting RSM and drug substance CMC strategy activities (scope dependent on level).

• Domestic and international travel required (approximately 10–20%).

Minimum Qualifications:

• Advanced degree in chemistry, chemical engineering, or a related field; PhD strongly preferred.

• 7+ years of relevant experience in CMC, process chemistry or drug substance/API development and manufacturing, including demonstrated leadership of starting material or CMC regulatory strategy programs.

• Demonstrated experience supporting late‑stage clinical and/or commercial drug substance programs.

• Deep working knowledge of ICH Q11 and applicable regional guidance/expectations governing the selection and justification of Regulatory Starting Materials.

• Demonstrated experience authoring and defending CMC regulatory submission content, including direct experience in health authority interactions related to starting material or drug substance manufacturing strategy.

• Strong background in synthetic/process chemistry, with the ability to critically evaluate route scouting, impurity control strategy, and structural relevance arguments for candidate starting materials.

• Experience managing relationships with drug substance/API CMOs and raw material suppliers, including batch record reviews and overarching manufacturing oversight.

• Working knowledge of cGMP requirements as they apply to drug substance manufacturing and the GMP/non‑GMP boundary.

• Experience supporting technology transfer of drug substance processes from clinical to commercial scale preferred.

• Strong leadership, cross‑functional collaboration, and scientific writing/communication skills; exercises judgment within broadly defined practices and policies in determining solutions and actions.

• Demonstrated ability to identify and address starting material‑related risks that could jeopardize regulatory timelines, supply, or overall program success.

Work Location:

• The Associate Director, Regulatory Starting Material role is 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

$126,000 - $268,400

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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