- Deep technical knowledge of synthetic molecule CMC drug development and commercialization.
- Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations.
- Development of regulatory strategy and update strategy based upon global regulatory changes.
- 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 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 (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
- Minimum of seven years of technical CMC experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing. Additional Skills/Preferences
- Demonstrated deep technical knowledge of the synthetic molecule drug development and commercialization process.
- Experience authoring CMC submission content, and involvement in CTA/MAA processes including response to questions.
- Prior regulatory CMC experience supporting clinical phases of development, commercialization and/or post-approval submissions for synthetic molecules.
- Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives desirable.
- Knowledge in new molecular modalities (e.g., oligonucleotides, synthetic peptides) or new manufacturing technologies (e.g., continuous manufacturing).
- 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
- Travel: minimal within the US 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 ( ) 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. 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. #WeAreLilly -
Food Regulatory Affairs Specialist
3 weeks ago
Talent Acquisition Inc Marion, United StatesThe Food Regulatory Affairs Specialist will be responsible for ensuring all claims made on packaging are met within regulatory requirements, as well as maintaining good standing with our regulatory bodies. · Duties: · Maintain certification status of both the facility and indiv ...
-
Regulatory Affairs
3 weeks ago
iRiS Recruiting Solutions Shelbyville, United StatesRegulatory Affairs · Regulatory Affairs SME · Compensation: $110,000 to $130,000 · Location: Shelbyville, IN · ABOUT OUR CLIENT: · Our client is a leader in their space, in SE Indianapolis. Their state-of-the-art facility will · be where groundbreaking ideas become reality. ...
-
Regulatory Affairs
1 week ago
iRiS Recruiting Solutions Shelbyville, United StatesRegulatory Affairs · Regulatory Affairs SME · Compensation: $110,000 to $130,000 · Location: Shelbyville, IN · ABOUT OUR CLIENT: · Our client is a leader in their space, in SE Indianapolis. Their state-of-the-art facility will be where groundbreaking ideas become reality. Th ...
-
Eli Lilly and Company Indianapolis, United States Full timeAt 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 th ...
-
Senior Regulatory Affairs Specialist
1 week ago
Yushiro Manufacturing America, Inc. Shelbyville, United StatesSenior Regulatory Affairs Specialist · Summary: · The Senior Regulatory Affairs Specialist at Yushiro is responsible for all regulatory functions associated with Yushiro's business. This person will provide advice and guidance to the organization on regulatory issues. Specific ar ...
-
Senior Regulatory Affairs Specialist
1 week ago
Yushiro Manufacturing America Shelbyville, United StatesSenior Regulatory Affairs Specialist · Summary: · The Senior Regulatory Affairs Specialist at Yushiro is responsible for all regulatory functions associated with Yushiros business. This person will provide advice and guidance to the organization on regulatory issues. Specific a ...
-
Senior Regulatory Affairs Specialist
1 week ago
Yushiro Manufacturing America Shelbyville, United StatesSenior Regulatory Affairs Specialist · Summary: · The Senior Regulatory Affairs Specialist at Yushiro is responsible for all regulatory functions associated with Yushiros business. This person will provide advice and guidance to the organization on regulatory issues. Specific a ...
-
Senior Manager Regulatory Affairs
2 weeks ago
Curium Live Forward Noblesville, United States TemporarySummary of Position · The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant conten ...
-
Field Clinical Specialist, Indianapolis
4 days ago
Edwards Lifesciences Indianapolis, United StatesAortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve rep ...
-
Health Policy Director
3 weeks ago
Elevance Health Indianapolis, United States· Health Policy Director · Location: This position will work a hybrid model (remote and office). The ideal candidate will live within 50 miles of one of our Elevance Health PulsePoint locations in Washington DC, Atlanta, GA, Mason, OH, Indianapolis, IN. · The Health Policy Direc ...
-
Senior Quality Specialist
4 weeks ago
Harba Solutions Inc. Indiana, United StatesJob Responsibilities: · Lead and manage quality assurance activities within the pharmaceutical manufacturing facility, including but not limited to batch record review, deviation management, change control, and CAPA (Corrective and Preventive Action) implementation. · Serve as th ...
-
Sr. Director Regulatory Scientists
2 weeks ago
Eli Lilly and Company Indianapolis, United StatesAt 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 th ...
-
GMP Engineer
2 weeks ago
Pivot Workforce, LLC Indianapolis, United StatesGMP Engineer · Department: Program Management/Quality Control · Reports to: Director of Program Management · Job Summary: · Seeking a Commissioning and Qualification Specialist to ensure systems, equipment, and processes meet regulatory and quality standards. Join our team to pla ...
-
Clinical Program Lead
2 weeks ago
Hoffmann-La Roche Ltd Indianapolis, United States Full timeRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we ...
-
Full-Time Audiologist
1 week ago
HealthDrive Corporation Indianapolis, United States Full timeOverview · HealthDrive is currently seeking an Audiologist to work Full-Time (5 Days per week) in Central/Southeast Indiana (Indianapolis, Richmond, Jeffersonville, Bloomington areas). · $100k Base with addtional earning opportuity, PLUS $5k sign-on bonus, all available at 5 days ...
-
Sr. Principal Associate
2 weeks ago
Eli Lilly and Company Indianapolis, United States Full timeAt 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 th ...
-
Sr. Principal Associate
1 week ago
Lilly Indianapolis, United StatesAt 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 th ...
-
Clinical Research Scientist, GPS Medical
3 weeks ago
Eli Lilly and Company Indianapolis, United States Full timeAt 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 th ...
-
Regional Clinical Manager
3 weeks ago
Amedisys Inc. Indianapolis, United StatesOverview Full Time Day Position Responsible for working directly with Care Center as assigned, temporarily filling open care center Clinical Manager positions, and taking responsibility and accountability for the position assigned. Provides oversight of care center clinical opera ...
-
Asst Registrar
3 weeks ago
Ivy Tech Community College Indianapolis, United StatesWho We Are: · We are a diverse open-access college that fuels Indiana's economy through excellence in teaching and proactive engagement with industry and community partners, embedded in a culture of innovation that empowers all students to learn and succeed. We are "higher educat ...
Senior Advisor/Director, Global Regulatory Affairs - Indianapolis, United States - Eli Lilly and Company
Description
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.
Senior Advisor/Director, Global Regulatory Affairs – CMC, Small Molecules
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 CMC scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world.
The Senior Advisor/Director in Global Regulatory Affairs – CMC Small Molecules 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 synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides. The regulatory scientist will be expected to leverage innovative regulatory strategies that can accelerate the development of assigned product(s).
Key responsibilities:
