Global Regulatory CMC Director, Peptides & Oligonucleotides
Eli Lilly and Company
Eli Lilly and Company located in Indianapolis is seeking an experienced regulatory CMC leader to support the development of synthetic peptides and oligonucleotides. The role demands a strong understanding of global regulations, combined with technical expertise in CMC processes. Responsibilities include leading regulatory submissions and providing strategic guidance to development teams. The ideal candidate has over 10 years of relevant experience and a degree in a science or engineering field. A comprehensive benefits program and competitive compensation are offered. #J-18808-Ljbffr Eli Lilly and Company
$148.5k - $257.4k
...strategic, tactical, and operational regulatory CMC leadership across advanced... ...accelerate development of the synthetic peptides and oligonucleotide portfolio, supporting clinical trial... ...through a strong working knowledge of global regulations, guidelines, and regulatory...SuggestedFlexible hours$148.5k - $257.4k
...discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our... ...world.This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing...SuggestedRemote workRelocation packageFlexible hours$148.5k - $257.4k
...around the world. We are a global healthcare leader headquartered... ...small molecules, synthetic peptides, oligonucleotides, and other emerging... ...manufacturing, and controls (CMC) of oligonucleotides to participate... ...commercialization, and regulatory submissions of...SuggestedContract workLocal areaFlexible hours$148.5k - $257.4k
...for people around the world. We are a global healthcare leader headquartered in... ...development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel... ...development to enable clinical trials, regulatory submissions, and new product...SuggestedTemporary workLocal areaFlexible 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 of...SuggestedLocal areaRemote workRelocationFlexible hours$148.5k - $257.4k
...life better for people around the world. We are a global healthcare leader headquartered in Indianapolis,... ...for analytical characterization and development of oligonucleotides, antibody-oligonucleotide conjugates and peptide-oligonucleotide conjugates. The Analytical team...Temporary workFlexible hours- Initial Therapeutics, Inc. seeks a Global Regulatory Lead in Indianapolis, IN. The role involves developing regulatory strategies, overseeing FDA interactions, and leading a cross-functional team. Candidates must possess an advanced scientific degree and substantial experience...Relocation package
$154.5k - $226.6k
...discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our... ...business partners including but not limited to Medical, Legal, Regulatory, Privacy, Protect Lilly, Finance, Procurement, and Human...Full timeH1bWork at officeLocal areaVisa sponsorshipWork visaFlexible hours$135k - $190k
...innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory. It’s all part of our... ...leadership through change.This position reports to the Senior Director, Global Commercial Operations & Enablement and Organizational Transformationand...Full timeContract workPart timeRemote workWork from homeFlexible hours- Join to apply for the Associate Director - Engineering API EM Peptides & LM role at BioSpace At Lilly, we unite... ...for people around the world. We are a global healthcare leader headquartered in... ...commercialization (Validation, Tech Transfer, CMC, GMP, Quality, and/or HSE)...Contract workWork experience placement
$148.5k - $257.4k
...includes small molecules, synthetic peptides, oligonucleotides, antibody-drug conjugates (... ....SMDD is seeking a Director / Senior Director / Executive... ...biowaiver strategies, authoring CMC and biopharmaceutics regulatory content for global submissions and responses to...Temporary workImmediate startFlexible hours$148.5k - $257.4k
...around the world. We are a global healthcare leader... ...product commercialization, and regulatory submissions. The position... ...techniques to address key CMC challengesLead and/or supervise... ...of small molecule, oligonucleotide, and synthetic peptide, and other emerging synthetic...Temporary workFlexible hours- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology Type Public Company About the Role The Company is seeking a Head of Global Regulatory Advertising and Promotion...
$141.52k - $171.48k
...pioneering spirit of an emergent biotech with the global expertise and resources of a leading... ...of Chemistry, Manufacturing & Controls (CMC) - Quality Assurance develops and drives... ...Quality organization. Collaborate with Regulatory to track/own Quality input for ongoing...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours$177k - $308k
...discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our... ...AI-enabled drug development while ensuring scientific rigor, regulatory defensibility, and meaningful value creation.Key...Flexible hours- ...ELAN) - it all starts with animals!As a global leader in animal health, we are... ...join our team today!Your RoleAs Associate Director, Regulatory Affairs - Biologics, you will lead regulatory... ..., ideally biologics/vaccines or CMC, who has owned regulatory strategy, submissions...Full timeSummer workRelocationFlexible hours
- ...professional to help ensure financial reporting integrity. This role focuses on risk assessment, control documentation, and coordinating global testing with Internal Audit and external partners. You will work with process owners to remediate deficiencies, support new control...
- A global healthcare leader is seeking a Director for CMCPM Radiopharmaceuticals in Indianapolis. The role involves leading the creation and implementation of CMC plans, collaborating with global program teams to drive CMC development and delivery goals. Candidates should...Remote job
$163.4k - $322.1k
...clients and incremental revenue to the firm across Deloitte’s global network. Recruiting for this role ends on 09/04/2026. Work You’... ...reporting directly to the Lead Alliance Partner (LAP) and maintaining Director+ relationships across strategic business functions and market...Local area- A global healthcare leader in Indianapolis is looking for a Sr. Director of the Global Medicines Quality Organization. This role encompasses leadership in quality assurance... ...degree and a minimum of 10 years in quality or regulatory fields. Strong problem-solving, communication,...
- ...organizations in over 100 countries - moving AI from possibility to production in real-world enterprise environments every day.Role Overview:Global go to market planning at scale requires disciplined coordination across strategy, operations, and execution. This role shapes how...Full timeWork from homeWorldwideFlexible hoursShift work
- ...ELAN) - it all starts with animals!As a global leader in animal health, we are dedicated... ...our team today!Your Role: Feed Additive Regulatory Specialist The Feed Additive Regulatory Specialist... ...requirements (Safety, Efficacy, CMC, Labeling) and guide project teams by coordinating...Full timeSummer workRelocationFlexible hours
$123k - $180.4k
...people around the world. We are a global healthcare leader... ...and highly motivated Associate Director to join our Technical Services... ...TS/MS) team, specializing in Peptides. In this role, you will provide... ...successful scale-up, validation, and regulatory compliance.* Design, execute,...Flexible hours$148.5k - $257.4k
...around the world. We are a global healthcare leader... ...small molecules, synthetic peptides, oligonucleotides, antibody-drug conjugates... ...to enable clinical trials, regulatory submissions, and new product... ...of analytical scientists. Directors in this role will be responsible...Temporary workWorldwideFlexible hours$118.5k - $173.8k
A global healthcare leader in Indianapolis is seeking an Associate Director for Peptide Operations. This role leads frontline teams to ensure the accurate execution of manufacturing processes, fostering a culture of operational excellence. The ideal candidate has a B.S....- ...coordinating with logistics, procurement, sales and finance to maintain auditable records. This role emphasizes accurate documentation, regulatory filings, and collaboration with customs brokers to keep shipments compliant and moving efficiently, while supporting internal...
- A global healthcare leader in Indianapolis is seeking a Director for their Cardiometabolic Health Global Medical Affairs team. This role involves strategic oversight of health economic and outcomes research to support drug development, working closely with various therapeutic...
- ...Regulatory Affairs Specialist Location: Indianapolis, IN Duration: 18+ Months Description... ...ON RESUME: 3+ years experience in a CMC/Chemistry Manufacturing and Controls position... ...RA Scientists, the various aspects of global clinical trial and marketing...Work at office
$198k - $356.4k
...discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our... ...) Collaborate with clinical development to support global regulatory requests (data generation, analysis, or dissemination) Offer scientific...Full timeFlexible hours- 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...
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