Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Inn[...]

Eli Lilly and Company; Indiana (PA); On-site; USD 148,500 - 257,400; Full time

Benefits offered by this job

Relocation assistance

Comprehensive benefits package

401(k) and pension plans

Job summary

Eli Lilly and Company is seeking a Regulatory CMC Expert in Indianapolis, IN, with the possibility of remote work. This role demands deep expertise in small molecule CMC drug development and significant regulatory experience. Candidates should possess a B.S. in a relevant STEM field and over ten years in regulatory CMC. The anticipated wage ranges from $148,500 to $257,400, accompanied by comprehensive benefits including 401(k) and healthcare. Join us in making life better for people worldwide.

Qualifications

• Ten or more years of regulatory CMC or technical CMC experience supporting clinical phases of development.
• Experience authoring CMC submission content.
• Knowledge of major market procedures and evolving regulatory initiatives.

Responsibilities

• Provide regulatory guidance to allow CMC development teams to make informed decisions.
• Lead preparation and approval of CMC documents for regulatory submissions.
• Assess and manage risk in a highly regulated environment.

Skills

Deep technical knowledge of small molecule CMC drug development

Regulatory CMC experience

Strong communication skills

Leadership and negotiation skills

Analytical thinking

Education

B.S. degree in a science or engineering field

Advanced degree preferred

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for people who are determined to make life better for people around the world.

Key Responsibilities

• Deep technical knowledge of small molecule CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).
• Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations and maintaining approved registrations.
• Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment (new guidance, evolving expectations, and regulatory precedent).
• Provide regulatory guidance to allow CMC development teams to make well‑informed decisions on development or product lifecycle planning.
• Lead preparation, critical review, and approval of CMC documents for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and health authority information requests.
• Takes a proactive leadership role in the critical review of molecule‑specific CMC development and lifecycle strategies.
• Provides high‑quality, timely and clear regulatory advice to allow project teams to make well‑informed decisions on development or product lifecycle planning.
• Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.

Basic Qualifications / Requirements

• B.S. degree in a science, engineering, or a STEM‑related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
• Ten or more years of regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules. Those with greater than ten years of experience are encouraged to apply.

Additional Skills / Preferences

• Experience authoring CMC submission content, and involvement in clinical trial applications/marketing authorization application processes including response to questions.
• Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives.
• Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.
• Demonstrated deep knowledge of the synthetic molecule drug development process.
• Extensive prior regulatory experience handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.
• Experience planning for and participating in Health Authority meetings.
• Demonstrated ability to assess and manage risk in a highly regulated environment.
• Demonstrated strong written, spoken and presentation communication skills.
• Demonstrated leadership behaviors and negotiation and influence skills.
• Demonstrated attention to detail.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Additional Information

• Position Location: Indianapolis, IN. A remote option may be considered. Relocation assistance is provided.
• Travel: minimal within the US.

Compensation & Benefits

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 will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program that includes eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits such as healthcare or dependent day‑care flexible spending accounts; life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (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.

Equal Opportunity Employer

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.