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
$156k - $253k
...world. We are a global healthcare... ...from building a molecule, through developing... ...through regulatory submission and... ...assets including small molecules, peptides... ...seeking a Senior Director / Executive... ...SMDD’s technical strategy. Evaluate the organization... .... 10+ years of CMC experience....SuggestedFull timeWork experience placementH1bWorldwideFlexible hours$148.5k - $257.4k
...strategic, tactical, and operational regulatory CMC leadership across advanced... ...conjugation, characterization, and control strategies). Knowledge of global CMC regulatory requirements and... ...leadership role in the critical review of molecule-specific CMC development and...SuggestedFull timeFlexible hours$148.5k - $257.4k
...around the world. We are a global healthcare leader... ...world. The Synthetic Molecule Design and Development... ...portfolio that includes small molecules, synthetic... ...Our core commercial strategy centers on traditional... ...platforms. Familiarity with regulatory CMC requirements for...SuggestedFull timeFlexible hours- Eli Lilly and Company is seeking a Regulatory CMC leader in Indianapolis, Indiana. This role focuses on CMC leadership for synthetic peptides... ..., ensuring compliance and providing strategic guidance for global submissions. The ideal candidate will have over a decade of experience...SuggestedFull time
- ...located in Indianapolis, Indiana, is seeking a Senior Director / Executive Director, Small Molecule Chemistry to lead the late-stage development of small molecule... ...successful candidate will have extensive experience in CMC and a strong background in managing the...Suggested
$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$209.6k - $313.38k
...portfolio of development and marketed assets. The Medical Director, Global Medical Strategy is a key leader within medical affairs and serves as the... ...to support the HEOR, publications, marketing, sales, regulatory, and all other cross functional teams to ensure plans are...Temporary workLocal 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...
- ...Myers Squibb is seeking a Senior Manager of CMC - Quality Assurance in Indianapolis. This role will lead Quality strategies for the manufacturing and development of radiopharmaceuticals... ...to manage Quality inputs and ensure regulatory compliance. The position requires...
$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. Lead engagement... .... 2+ years implementing small and large systems/...Full timeRelocationVisa sponsorshipWork visaFlexible hours$132k - $193.6k
...us. Organization Overview The purpose of the Associate Director, Global Regulatory Affairs - Product Communications role is to provide leadership... ...actions. Contribute to business risk mitigation strategies by following trends in external environment related to advertising...Full timeH1bWork at officeVisa sponsorshipWork visaFlexible hours$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...- ...an emerging biotech with the global expertise and resources of a... ...Chemistry, Manufacturing & Controls (CMC) - Quality Assurance develops... ...and analytical) strategies for CMC activities (drug substance... ...organization. Collaborate with regulatory to track/own quality input...Hourly payTemporary workSummer workImmediate startFlexible 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....
- Allegion Canada Inc. is seeking a Vice President of Global Procurement in Carmel, Indiana, to lead the procurement function across multiple regions and divisions. This role involves strategic leadership in sourcing, managing a $1.25B spend, and ensuring compliance with...
$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...- ...Chief Strategy Officer (CSO) About the Company Accomplished medical device company Industry Medical Device Type Privately Held About the... ...materials. Additionally, the role involves extensive travel to global sites to gain a deep understanding of the company's operations...
- ## Manager, Regulatory AffairsApplyremote type: On Sitelocations: US,... ...'s leading the charge in the global energy revolution. With operations... ...is responsible for leading a small team responsible for... ...design.* Supports settlement strategy and negotiations.* Leads and...For contractorsWorldwide
- # Global Regulatory Project ManagerBack to search resultsApply to this positionFollow CompanyMore Jobs from Cortev...Send to FriendWho are... ...Global Regulatory Project Manager (GRPM) translates regulatory strategy and plans into actionable execution by developing...Local area1 day per week
- Eli Lilly and Company in Indianapolis seeks a Clinical Research Director to identify and deliver strategic initiatives for global clinical trials. You will develop and optimize oversight processes, lead integration efforts, and identify areas for process improvement. The...
$165k - $220k
...Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to... ...health in the future. The Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling... ...crossfunctionally with Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory...Temporary workWork visa$115.5k - $169.4k
...Associate Director, CMC Project Management At Lilly, we unite caring with discovery to make... ...better for people around the world. We are a global healthcare leader headquartered in... ...translate clinical, asset and portfolio strategy into clear CMC development and delivery...Full timeFlexible hours$87.4k - $253k
...We Are: Accenture Strategy - where bold ideas meet relentless execution. We sit at the intersection of business strategy and technological... ...on manufacturing, capacity, and ecosystem strategy, optimizing global supply-chain resilience and cost structures, or helping...Live inWork at officeLocal area- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage... ...activities. This includes global regulatory strategy, managing health authority interactions... ...health therapeutics and a background in small to mid-size biotech companies are also...
- ...Chief of Staff, Strategy & Operations About the Company Globally-focused staffing company providing affordable talent solutions Industry Staffing and Recruiting Type Privately Held Founded 2022 Employees 11-50 About the Role The Company...
$186.49k - $278.88k
...an innovative and strategic leader to serve as the Director, U.S. Neuroscience Pipeline & Portfolio Strategy. This individual is responsible for supporting Otsuka... ...brand strategy development, working closely with global and R&D, business development, and commercial teams...Temporary workLocal areaFlexible hoursShift work$186.9k - $234k
...architect of Rubrik's most critical industry partnerships. As a Global Alliances Director, you will orchestrate a massive cross-functional engine-... ...Veterans: Previous experience executing joint GTM strategies with Tier-1 vendors such as Pure Storage or Cisco ....Local areaRemote work$109.2k - $223.4k
...Job Description The Director for Global Defense - Japan is responsible for leading and growing... ...while operating within Japan’s regulatory, security, and procurement environment... ...ecosystem partners; shapes long-range capture strategy; and ensures secure delivery of...Contract workTemporary workFor contractorsLocal areaFlexible hours- ...Knowledge of drug development process, regulatory/business strategies and plans Demonstrated ability to... ...and is capable of representing Global Regulatory Affairs. Provide Regulatory... ...registration management process at the molecule/project level to ensure all required...Local area
$249.97k - $388.13k
...Position Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader... ...for driving the global value evidence strategy across the company's portfolio. This... ...evidence generation initiatives to support regulatory, HTA, and payer submissions, and...Temporary workLocal areaFlexible hours
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