Global CMC Regulatory Lead, Small Molecules
Initial Therapeutics, Inc.
Initial Therapeutics, Inc. seeks an experienced regulatory CMC leader in Indianapolis, IN. This position involves providing strategic oversight for small molecule drug development and ensuring compliance with global regulations. The successful candidate will have over 10 years of relevant experience and a strong educational background in science or engineering. Competitive compensation range is $148,500 - $257,400, with relocation assistance and a comprehensive benefits package offered. Remote options may be available. #J-18808-Ljbffr Initial Therapeutics, Inc.
- Lilly in Indianapolis, IN is seeking a Regulatory CMC leader to drive global submissions and lifecycle strategies for small molecule programs. You will provide strategic and operational guidance across clinical trials, marketing applications, and post-approval changes in...Regulatory
$148.5k - $257.4k
...around the world. We are a global healthcare leader headquartered... ..., tactical and operational regulatory CMC leadership across... ...expedite development of the small molecule portfolio and to support clinical... ...product lifecycle planning.Leads preparation, critical review...RegulatoryRemote workRelocation packageFlexible hours$169.5k - $248.6k
...for patients, we invite you to join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable decision maker for the... ...Global Regulatory Team inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global LabelingFoster a culture...RegulatoryLocal areaFlexible hours$148.5k - $257.4k
...strategic, tactical, and operational regulatory CMC leadership across advanced... ...strong working knowledge of global regulations, guidelines, and... ...and lifecycle planning.Lead preparation, critical review,... ...role in the critical review of molecule-specific CMC development and...RegulatoryFlexible hours- ...Indianapolis is seeking an experienced regulatory CMC leader to support the development of synthetic... ...role demands a strong understanding of global regulations, combined with technical... ...CMC processes. Responsibilities include leading regulatory submissions and providing strategic...Regulatory
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- ...in cardiovascular diseases to lead clinical development across cardio... ...with preclinical teams and regulatory authorities. The position requires oversight of global trials, rigorous safety reviews... ...with external experts to advance molecules and adapt development plans to...Regulatory
- Lilly is seeking a Global Regulatory Lead (GRL) to own global regulatory strategies from entry through end of life. You will lead a cross-functional Global Regulatory Team and manage the US FDA relationship, shaping development plans and regulatory submissions. This role...RegulatoryRelocation package
- Eli Lilly and Company in Indianapolis, IN is seeking a Global Regulatory Lead (GRL) to serve as the accountable decision maker for global regulatory strategies—from portfolio entry through end of life. You will build and lead the Global Regulatory Team, and manage interactions...RegulatoryLocal area
- Lilly in Indianapolis, Indiana, is seeking a Global Regulatory Lead to guide global regulatory strategies and oversee FDA submissions from early development through lifecycle. You will lead a cross-functional team and manage external stakeholder relationships to ensure...Regulatory
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$118k - $197k
...Elanco (NYSE: ELAN) - it all starts with animals!As a global leader in animal health, we are dedicated to... ...life better - join our team today!Your Role: Global Regulatory Project LeadAs the Global Regulatory Project Lead, you will be a key individual contributor at the forefront...RegulatoryFull timeSummer workLocal areaRemote workRelocationFlexible hours- Lilly, headquartered in Indianapolis, Indiana, seeks a Global Regulatory Lead to develop and execute global regulatory strategies and to own interactions with the US FDA. You will lead a cross-functional team, interact with the Global Brand Development team, and own regulatory...Regulatory
- ..., headquartered in Indianapolis, seeks a Lead role in Case Management Medical Review. You... ...medical review personnel, integrate regulatory and scientific expertise, and drive safety... ...evaluations across product life cycles in a global team. Role requires a health/science...Regulatory
- ...an Associate Director of RMS Quality to provide strategic leadership for quality systems across small animal and non-human primate operations. The role emphasizes regulatory compliance, animal welfare, and collaboration with operations and veterinary teams to promote quality...Regulatory
- Roche seeks a Regulatory Affairs leader to guide the Endocrinology and Fertility subchapter within Medical Value Assays. You will mentor... ...and international bodies, and drive regulatory strategies across global projects. Based in a global role with travel, you will...Regulatory
- ...Vice President of Toxicology, Small Molecules About the Company Clinical-stage biopharmaceutical... ...discovery to clinical development and regulatory stages. This role demands a visionary... ...will have a proven track record of leading cross-functional teams, be adept at...Regulatory
$126k - $204.6k
...people around the world. We are a global healthcare leader... ...Position SummaryAt Lilly, the molecules that become medicines start as... ...science move faster.The Scientific Lead is responsible for operational... ...multi-modality sample types (small molecules, peptides, biologics...Full timeFor contractorsFlexible hours- Lilly in Indianapolis is seeking a Global Regulatory Lead to steer global regulatory strategies from portfolio entry through end of lifecycle. You will build and lead the Global Regulatory Team, and act as the primary regulatory voice on the Global Brand Development team...Regulatory
$151.5k - $264k
...At Lilly, Synthetic Molecule Design and... ...energetic candidates to lead unit operation development... ...clinical trials, regulatory submission, and... ...to a portfolio of small molecule, oligonucleotide... ...of the external global regulatory climate... ...Ability to address key CMC regulatory...RegulatoryTemporary workLocal areaFlexible hours- Wurth Industry US is seeking a Regulatory Compliance Officer for their Greenwood, Indiana location. The role is crucial in ensuring adherence to U.S. and international export regulations, overseeing the Export Compliance Program that includes licensing, classifications...Regulatory
- Elanco seeks a Feed Additive Regulatory Specialist to lead regulatory affairs for the US feed additive and... ...will define registration requirements (CMC, Safety, Efficacy) and guide project... ...regulations. You’ll collaborate with global technical functions and the US Affiliate...Regulatory
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