Advisor/Sr. Advisor – Regulatory Scientist – Global Regulatory Affairs CMC-Parenteral Commercial Products Full-time

Regulatory Scientist GRA CMC-Parenteral Commercial Products

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 regulatory Chemistry, Manufacturing and Control (CMC) scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world.

We are seeking a Regulatory Scientist GRA CMC-Parenteral Commercial Products to be a part of the Lilly post-approval regulatory group to support global submissions and registrations. As the project leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support for market registrations and post-approval submissions. The regulatory scientist will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the bioproduct portfolio. The regulatory scientist will be expected to develop and implement innovative regulatory strategies to advance the development of assigned product(s).

Key responsibilities / expectations:

• Deep technical knowledge of CMC drug development science(s)
• Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product manufacturing and obtaining global product marketing registrations
• Development of regulatory strategy to ensure alignment with current and evolving global regulatory expectations
• Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning
• Leads preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questions
• Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content
• Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members

Minimum Requirements

• B.S. degree in a science, engineering, or a related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar) with a minimum of 7+ years of regulatory CMC experience supporting clinical phases of development and/or commercialization. Experience should include authoring CMC submission content and involvement in commercial submission processes including response to questions.

OR

• Advanced degree (PhD, MS) in a science, engineering or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar) with a minimum of 4+ years of regulatory CMC experience supporting clinical phases of development and/or commercialization. Experience should include authoring CMC submission content and involvement in commercial submission processes including response to questions.

Preferred Experiences and Skills

• Experience in parenteral drug product development, commercialization or manufacturing
• Demonstrated knowledge of the biologic drug development process.
• Knowledge of major market procedures, regulations and practices. Awareness of evolving regulatory initiatives desirable.
• Experience planning for and participating in Health Authority meetings
• Demonstrated ability to assess and manage risk in a highly regulated environment.
• Demonstrated strong written, verbal 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
• 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 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 – $198,000. 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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