Global Regulatory CMC Director — Small Molecule Strategy
Eli Lilly & Co
Eli Lilly and Company is seeking a CMC Regulatory Leader in Indianapolis, Indiana. This full-time position requires a B.S. degree in science or engineering, with 10+ years of experience in Regulatory CMC. The role involves providing strategic and operational regulatory leadership across therapeutic modalities to support clinical trials and product registrations. Candidates must have strong leadership, analytical, and communication skills, along with deep technical knowledge in drug development. A remote option may be considered. #J-18808-Ljbffr Eli Lilly and Company
- Dormont Manufacturing Co is seeking a Regulatory CMC Leader based in Indianapolis, IN. This... ...operational regulatory leadership across small molecule drug development and manufacturing... ...Candidates should have deep knowledge of global CMC regulatory requirements and a...SuggestedFull time
$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... ...of innovative regulatory strategies and platform approaches based...SuggestedFull timeRemote workRelocation packageFlexible hours$156k - $253k
...Overview We are seeking a Senior Director - Late Stage Small Molecule Chemistry to provide... ...teams including Quality, Regulatory, and manufacturing to ensure... ...of SMDD’s technical strategy. Evaluate the organization... ...experience. 10+ years of CMC experience. Direct experience...SuggestedFull timeWork experience placementFlexible hours- ...it all starts with animals! As a global leader in animal health, we are... ...join our team today! Your Role: Director, Global CMC Regulatory Affairs - Biocides/Pesticides, Topicals... ...instrumental in developing regulatory strategies, overseeing submission preparation,...SuggestedSummer workRelocationFlexible hours
- ...Director, Global CMC Regulatory Affairs – Biocides/Pesticides, Topicals and Collars At Elanco – it all starts with animals! As a global leader... .... You'll be instrumental in developing regulatory strategies, overseeing submission preparation, and ensuring compliance...SuggestedSummer workRelocationFlexible hours
- ...We are growing our Regulatory Affairs organization... ...professional to support global Regulatory CMC activities across... ...maintenance of CMC regulatory strategies to enable successful... ...with the Senior Director of Regulatory CMC... ...of NCEs / small molecules/biologics/combination...
- ...biopharmaceutical company in Carmel, Indiana, is seeking a Regulatory Affairs professional to support global regulatory CMC activities. This role involves collaborating on... ...clinical programs and managing CMC regulatory strategies. The ideal candidate will have over 10 years of...
- A leading animal health company is seeking an Advisor for CMC Regulatory Affairs - Biologicals in Indianapolis, IN. In this pivotal role, you will provide strategic regulatory guidance to maintain global product registrations and availability, improving overall regulatory...
$156k - $253k
Eli Lilly and Company seeks a Senior Director for Late Stage Small Molecule Chemistry to lead a high-performance team in Indianapolis. This role involves... .... The ideal candidate will have over 10 years of CMC experience and a Ph.D. in a relevant field. Competitive...$177k - $308k
...better for people around the world. We are a global healthcare leader headquartered in... ...committed to using its innovation-based strategy to discover, develop and deliver innovative... ...while ensuring scientific rigor, regulatory defensibility, and meaningful value creation...Full timeFlexible hours$150.03k - $224.25k
...Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global investigational and... ...members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.)...Temporary workWork at officeLocal areaFlexible hours- ...senior leader to drive its enterprise-wide intellectual property strategy from Indianapolis, Indiana. The role involves advising... ...IP matters, protecting and enforcing IP assets, and managing a small team of IP professionals. A Juris Doctor (J.D.) with a minimum...
$209.6k - $313.38k
...Company Overview: Otsuka is a global healthcare company driven by... ...and experienced Medical Director of CNS Early Assets, Global Medical... ...to the broader overall TA strategy determined by the Sr.... ...the US healthcare system and regulatory landscape is required for this...Temporary workLocal areaFlexible hours$169.5k - $248.6k
...around the world. We are a global healthcare leader headquartered... ...The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory... ...global regulatory strategies for product(s) in the assigned... ...GRA central functions, GRA-CMC, GRA-Devices, and regional...Full timeLocal areaRelocationFlexible hours- ...Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) At Lilly, we unite caring... ...implement innovative global regulatory strategies for products in the assigned... ...inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory...Local area
$156k - $228.8k
Initial Therapeutics, Inc. is seeking a Sr Director of Corporate HSE in Indianapolis. This role involves leadership over global HSE programs, including compliance and risk... ...oversight of auditing, and the development of HSE strategies. An ideal candidate has a Bachelor's degree...$154.5k - $226.6k
...people around the world. We are a global healthcare leader... ...Objectives/Deliverables Operational Strategy & Day-to-Day Execution Own and... ...drive efficiency and meet regulatory, privacy, and quality standards... ...for the Lilly Cares Board of Directors, including preparation for...Full timeH1bVisa sponsorshipWork visaFlexible hours$115.5k - $169.4k
...around the world. We are a global healthcare leader headquartered... ...purpose of the Associate Director PV Systems Strategy and Implementation is to... ...and Quality to deliver upon regulatory and audit requests. Leads engagement... .... 2+ years implementing small and large systems/...Full timeH1bRelocationVisa sponsorshipWork visaFlexible hours- Finance & Strategy Manager, Professional Services - Global Delivery Join to apply for the Finance & Strategy Manager, Professional Services - Global Delivery role at Salesforce Job Overview We are seeking a Finance & Strategy Manager to join our Global Delivery team at...3 days per week
$117k - $171.6k
...for people around the world. We are a global healthcare leader headquartered in... ...responsible for integrating Manufacturing CMC elements to support molecule commercialization and to manage the... ...CM&C teams in developing strategies and implementing operational plans to...Full timeFlexible hours$135k - $190k
...by scientists, with many of our 3,300+ global colleagues coming from the laboratory.... ...profitable growth through disciplined contract strategy, bid and tender excellence, and large... ...This position reports to the Senior Director, Global Commercial Operations & Enablement...Contract workPart timeRemote workWork from homeFlexible hours- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology... ...lead the development and execution of the global regulatory strategy for advertising and promotion across its marketed products....
$198k - $356.4k
...people around the world. We are a global healthcare leader... ...role in shaping the scientific strategy and ensuring impactful dissemination... ...and enthusiasm for the molecule and the program through data... ...development to support global regulatory requests (data generation, analysis...Full timeFlexible hours- Labcorp is seeking a Global Director Genomics to lead the team in Indianapolis, IN. This position is vital for driving performance in global laboratory operations, enhancing scientific capabilities, and ensuring compliance and client satisfaction. Ideal candidates should...
$163.5k - $239.8k
Initial Therapeutics, Inc. is seeking a Senior Director for Components and Materials to lead strategic initiatives in Indianapolis. This role involves overseeing the global network for Primary Packaging Components and driving compliance and operational excellence. Candidates...- A leading automotive transmission company in Indianapolis is seeking a Transfer Pricing Manager to oversee U.S. international tax compliance and support audit processes. The ideal candidate will have over 7 years of corporate income tax experience, with at least 5 years...
$150.03k - $224.25k
...Summary The Associate Director, Quality Operations... ..., and optimize global quality system processes... ...effective change management strategies are applied to drive... ...comply with global regulatory requirements (e.g.,... ...exposure to both small molecule and biologics. ~ Strong...Temporary workLocal areaFlexible hours$157.5k - $231k
Lilly is seeking a Senior Director of Global Cyber Compliance in Indianapolis to lead compliance... ...and oversee a multi-framework regulatory environment. The successful candidate... ...define and own the global compliance strategy, apply AI to enhance processes, and ensure...$157.5k - $231k
...people around the world. We are a global healthcare leader... ...Cybersecurity is seeking a Senior Director of Global Cyber Compliance to... ...program that measurably reduces regulatory risk across Lilly's global... ...environment. This leader owns strategy and execution across a complex...Full timeH1bImmediate startVisa sponsorshipWork visaFlexible hours$156k - $228.8k
Lilly in Indianapolis, Indiana is looking for a Senior Director of Corporate HSE. This role involves providing leadership and oversight for global HSE programs, ensuring compliance with industrial standards, and leading a high-performing team to drive safety initiatives...
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