Eli Lilly

Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Innovation - Synthetic Peptides and Oligonucleotides

Eli Lilly • $148K — $257K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • B.S. degree in a science or engineering field (advanced degree preferred)
  • 10+ years of Regulatory CMC or technical CMC experience in synthetic peptides, oligonucleotides, or complex modalities
  • Experience with CMC submission content for peptides/oligonucleotides
  • Knowledge of global regulatory procedures and expectations for complex modalities
  • Leadership capability with strong negotiation and influencing skills

Responsibilities

  • Lead the strategic development and execution of regulatory CMC plans for advanced therapeutic modalities
  • Advise CMC development teams on regulatory strategy and lifecycle management
  • Prepare and critically review CMC documentation for global submissions
  • Innovate regulatory strategies to accommodate evolving guidelines and modalities
  • Provide clear regulatory advice to project teams to facilitate complex development processes
  • Manage molecule-specific CMC strategies, focusing on nuances in peptides and oligonucleotides
  • Coordinate decision-making on global CMC regulatory strategies

Benefits

  • Eligibility for company-sponsored 401(k) and pension
  • Comprehensive medical, dental, and vision insurance
  • Flexible spending accounts for healthcare and dependent care
  • Vacation and leave of absence benefits
  • Life insurance and wellbeing programs, including fitness benefits and employee assistance programs
Full Job Description
This role provides strategic, tactical, and operational regulatory CMC leadership across advanced therapeutic modalities and manufacturing technologies to accelerate development of the synthetic peptides and oligonucleotide portfolio, supporting clinical trial applications, market registrations, and post-approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory precedent, coupled with deep technical expertise in CMC development and manufacturing processes specific to synthetic peptides and oligonucleotides.

Key Responsibilities
  • Deep technical knowledge of synthetic peptide and oligonucleotide CMC drug development and manufacturing sciences across modalities and platforms, including drug substance, drug product, and analytical sciences (e.g., solid-phase synthesis, purification, conjugation, characterization, and control strategies).
  • Knowledge of global CMC regulatory requirements and guidelines for synthetic peptides and oligonucleotides to support clinical development, global product registrations, and lifecycle management of approved products.
  • Development and implementation of innovative regulatory strategies and platform-based approaches, incorporating evolving external expectations (e.g., emerging guidance, novel modality considerations, and regulatory precedent).
  • Provide regulatory guidance enabling CMC development teams to make well-informed decisions on development strategies and lifecycle planning.
  • Lead preparation, critical review, and approval of CMC documentation for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and responses to health authority queries.
  • Take a proactive leadership role in the critical review of molecule-specific CMC development and lifecycle strategies, including considerations unique to peptides and oligonucleotides (e.g., impurity profiles, sequence-related variants, delivery systems, and stability).
  • Provide high-quality, timely, and clear regulatory advice to support project teams in advancing complex modalities.
  • Make decisions on CMC regulatory strategies impacting global submissions, ensuring alignment across geographies, teams, and platform approaches.

Basic Qualifications/Requirements
  • B.S. degree in a science, engineering, or related STEM field (advanced degree preferred), such as Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biochemistry, Molecular Biology, or similar.
  • 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides, oligonucleotides, or related complex modalities. Candidates with broader experience in advanced modalities are encouraged to apply.

Additional Skills/Preferences
  • Experience authoring CMC submission content for peptides and/or oligonucleotides, including participation in clinical trial and marketing authorization applications and responses to regulatory questions.
  • Knowledge of major global regulatory procedures, regulations, and evolving expectations for complex modalities, including platform technologies.
  • Relevant experience in peptide and/or oligonucleotide drug substance and/or drug product development, manufacturing, and commercialization.
  • Demonstrated understanding of key development considerations for peptides and oligonucleotides (e.g., synthesis scalability, impurity control, analytical characterization, stability, and delivery systems such as conjugates or lipid-based formulations).
  • Extensive regulatory experience managing complex submission strategies or equivalent combination of technical and regulatory expertise.
  • Experience planning for and participating in Health Authority interactions.
  • Demonstrated ability to assess and manage risk in a highly regulated and evolving modality space.
  • Strong written, verbal, and presentation communication skills.
  • Demonstrated leadership, with strong influencing and negotiation skills.
  • High attention to detail and commitment to quality.
  • Strong collaboration skills with ability to work effectively across diverse, cross-functional teams.


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$148,500 - $257,400

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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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