Eli Lilly

Director/Sr. Director Regulatory CMC, Lilly Regenerative Medicine

Eli Lilly • $163K — $281K *
Boston, MA 02115In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
4 days ago
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline required; advanced degree preferred.
  • 5+ years of regulatory CMC experience in gene therapy or ATMPs.
  • 5+ years of experience with global regulatory submissions and health authority interactions.
  • In-depth knowledge of guidelines for biologics and ATMPs (ICH, FDA, EMA).
  • Strong scientific understanding of gene therapy technologies and manufacturing processes.

Responsibilities

  • Develop and implement global regulatory CMC strategies for gene therapy programs.
  • Lead preparation and review of high-quality CMC sections for regulatory submissions.
  • Act as the primary regulatory liaison with health authorities for assigned projects.
  • Provide regulatory CMC guidance to cross-functional teams throughout the product lifecycle.
  • Identify and assess regulatory CMC risks, developing mitigation strategies.
  • Stay current with evolving global regulatory requirements for gene therapies.
  • Lead and mentor junior regulatory CMC professionals, fostering a culture of improvement.

Benefits

  • Company-sponsored 401(k) and pension plans.
  • Vacation and leave of absence benefits.
  • Comprehensive medical, dental, vision, and prescription drug coverage.
  • Flexible spending accounts for healthcare and dependent care.
  • Life insurance and additional death benefits.
  • Employee wellness programs including assistance programs and fitness benefits.
Full Job Description
Eli Lilly and Company is seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy portfolio. This role will be critical in shaping the regulatory path for novel gene therapies from early development through commercialization, ensuring compliance with global health authority requirements.

Job Responsibilities
  • Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions.
  • Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions, ensuring scientific accuracy, clarity, and adherence to regulatory guidelines.
  • Act as the primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) for assigned gene therapy projects, leading and facilitating interactions, teleconferences, and meetings.
  • Provide expert regulatory CMC guidance and support to cross-functional development teams (e.g., R&D, Manufacturing, Quality, Clinical) throughout the product lifecycle.
  • Proactively identify and assess regulatory CMC risks and opportunities, developing mitigation strategies and providing strategic recommendations to senior leadership.
  • Stay current with evolving global regulatory requirements, guidelines, and industry best practices pertaining to gene therapies and advanced therapeutic medicinal products (ATMPs).
  • Lead and mentor junior regulatory CMC professionals, encouraging a culture of excellence and continuous improvement.
  • Contribute to the development and improvement of internal regulatory CMC processes, standards, and templates.
  • Manage external consultants and contractors as needed to support regulatory CMC activities.


Minimum Requirements:
  • Education: Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required. An advanced degree (MS, Ph.D.) is strongly preferred.
  • Experience:
    • 5+ years of expertise in regulatory CMC for gene therapy, cell therapy, or other advanced therapeutic medicinal products (ATMPs).
    • 5+ years of experience with global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA, etc.).


Additional Preferences:
  • In-depth knowledge of global regulatory requirements and guidelines for biologics and ATMPs (e.g., ICH, FDA, EMA)
  • Strong scientific understanding of gene therapy technologies, manufacturing processes, and analytical methods.
  • Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely.
  • Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders.
  • Strategic thinker with strong problem-solving and decision-making abilities.
  • Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment.
  • Proficiency in regulatory information management systems and Microsoft Office Suite.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$163,500 - $281,600

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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