What are the responsibilities and job description for the Advisor/Sr. Advisor, Global Regulatory Affairs – CMC, Biotechnology position at Eli Lilly and Company?
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.
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
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 Biotechnology to be a part of the Lilly global 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 clinical trial applications and market registrations. The regulatory scientist in Global Regulatory Affairs – CMC Biotechnology will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and 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 bioproduct CMC global regulatory requirements and guidelines for conducting clinical trials 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
Preferred Experiences and Skills
Additional Information
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 an EEO / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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
Salary : $121,500 - $178,200
