Lilly Senior Regulatory Scientist - CMC in United States
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 35,000 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 Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Brand Description:
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 Senior Regulatory Scientist GRA-CMC Biotechnology to be a part of the Lilly global regulatory group to support global submissions and registrations and to lead the regulatory group at the Lilly RTP site. The purpose of this role is to provide strategic, tactical and operational direction to expedite CMC development of Lilly’s portfolio and technical agenda by supporting global market registration submissions, and post-approval submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes. To accomplish this purpose, it is necessary for the Senior Regulatory Scientist to develop collegial and mutually productive relationships across Lilly components, partner company components, and with Agency personnel. This role is further accomplished by a demonstrated ability to establish and/or to promote / refine key regulatory CMC positions and to effectively influence development, manufacturing, and GRA leadership on these positions.
Deep technical knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product biologic manufacturing
Development of regulatory strategy to ensure alignment with current and evolving global regulatory expectations
Provide regulatory guidance to site to all teams to make well-informed decisions on development or product lifecycle planning
Leads, preparation, review and finalization of CMC documents for registration and response to questions
Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.
Partners with Site Leadership and develops relationships with peers and line management to promote open discussion of issues to enable regulatory influence of drug development and manufacturing strategies
Partners with the broader GRA organization to develop consistent regulatory approaches across sites, promote continuous learning, and to incorporate regulatory feedback into new development or manufacturing plans
Facilitates FDA Regulated Products Annual Report
Supports RTP regulatory impact assessments for deviation and change management
3- 5 years of Bioproduct Regulatory CMC experience supporting clinical phases of development and/or commercialization, experience including authoring CMC submission content, and involvement in clinical trial and commercial processes including response to questions
Prior experience in parenteral drug product development, commercialization, or manufacturing
Excellent interpersonal, written and oral communication skills
Demonstrated leadership behaviors and negotiation and influence skills
Ability to handle multiple competing priorities
Advanced degree preferred
Experience in planning for and participating in Health Authority meetings and/or inspections
Demonstrated ability to assess and manage risk in a highly regulated environment
Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
Previous equipment qualification and process validation experience
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
- B.S. degree in a science, engineering, or a related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar)
The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.
Position may require some initial travel to Indianapolis to establish specific device knowledge and establish global contacts.
Minimal travel required
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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