Senior Advisor/Director Global Regulatory Affairs CMC – Commercial Product/Post Approval Scientist for Solid Oral Products Full-time

Senior Advisor/Director Post Approval Scientist

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 Senior Advisor/Director Post approval scientist in Global Regulatory Affairs – CMC commercial solid oral products will use 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 solid oral products. The regulatory scientist will be encouraged to demonstrate innovative regulatory strategies that support the lifecycle of the assigned product(s).

Key responsibilities:

• Deep technical knowledge of solid oral products CMC science and manufacturing processes.
• Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes and updating global product registrations.
• Develop and evaluate 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.
• Anticipate and resolve key technical or operational issues that could impact the function, CMC team and/or submission timing.
• Take on and independently manage challenging projects and identify creative and/or alternative solutions that support functional and partner organization requirements.
• Take 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.

• Make decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.
• Engage in site-specific regulatory activities to ensure maintaining registered commitments at the manufacturing site(s) for which they have responsibility for.

Basic Qualifications/Requirements

• B.S. degree in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
• 5+ years of Regulatory CMC experience and/or equivalent (such as time spent in supporting CMC functions for commercialization of solid oral products with regulatory submission experience). Those with greater than five-year experience are encouraged to apply.

Additional Skills/Preferences

• Demonstrated deep technical knowledge and experience of small molecule drug product development, commercialization and manufacturing processes.
• Prior regulatory CMC experience supporting commercialization and/or post-approval submissions for small molecule drug products, or equivalent combination of technical and regulatory guidance knowledge.
• Knowledge of major market procedures, regulations, and practices.
• Awareness of evolving global regulatory initiatives.
• 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 interpersonal styles

Additional Information

• Position Location: Indianapolis, IN. Remote option 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.

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 $144,000 – $211,200. 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.