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 give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Eli Lilly, we create medicines that give people new hope – to get better, feel better, live better. It’s our purpose to create medicines that make life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who need them all over the world.

The Advisor Post approval scientist in Global Regulatory Affairs – CMC Commercial Products will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies and submissions for Lilly’s commercial products. The regulatory scientist will be expected to leverage innovative regulatory strategies that support the lifecycle of the assigned product(s).

Key responsibilities:

Deep technical knowledge of synthetic molecule drug substance CMC science and manufacturing processes for conventional small molecules and/or synthetic peptides, proteins or oligonucleotide.
Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes and updating global product registrations.
Develops and evaluates global CMC regulatory strategies in collaboration with other regulatory, Manufacturing, Quality and project personnel to enable timely completion of submission milestones leading to health authoring approval.
Development of regulatory strategy and update strategy based upon global regulatory changes.
Provide regulatory guidance to allow CMC teams to make informed decisions on global registrations and product lifecycle planning.
Anticipates and resolves key technical or operational issues that could impact the function, CMC team and/or submission timing.
Takes on and independently manages challenging projects and identifies creative and/or alternative solutions that support functional and partners organization requirements.
Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval changes, line extensions or renewals, and responses to questions.

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 related field. Fields of study include Chemistry, Pharmacy or Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, Biochemistry, or similar.
7+ years of regulatory CMC or technical CMC experience in synthetic molecule drug substance development, commercialization or manufacturing.

Additional Skills/Preferences

Demonstrated deep technical knowledge and experience of synthetic molecule drug substance development, commercialization and manufacturing processes, including conventional small molecules and/or synthetic peptides, proteins or oligonucleotides.
Prior regulatory CMC experience supporting commercialization and/or post-approval submissions for synthetic drug substances, or equivalent combination of technical and regulatory guidance knowledge.
Knowledge of major market procedures, regulations, and practices. Awareness of evolving global regulatory initiatives desirable.
Experience planning for and/or 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 is not available.
Travel: minimal within the US

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$121,500 - $178,200

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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