Senior Global Regulatory Lead, Biologics & Vaccines
Elanco
Elanco is seeking an Associate Director, Regulatory Affairs for Biologics. This role involves leading regulatory strategy for biologics and vaccine programs that support Animal Health innovation. The ideal candidate will collaborate with R&D, Manufacturing, and other stakeholders. Qualified applicants will possess a Bachelor’s degree and a minimum of 5 years in Regulatory Affairs, particularly in biologics or vaccines. Elanco offers competitive benefits, including multiple relocation packages and flexible work arrangements. #J-18808-Ljbffr Elanco
$118k - $197k
Global Regulatory Project Lead As the Global Regulatory Project Lead, you will be a key individual contributor at the forefront of our innovation... ...Education: A Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a...SeniorRegulatorySummer workLocal areaRemote workRelocationFlexible hours- Lilly, headquartered in Indianapolis, IN, seeks a Regulatory CMC leader to guide biologics development and global submissions. You will apply deep regulatory knowledge to expedite clinical trials, registrations, and post‑approval activities, coordinating with cross‑functional...Regulatory
- Elanco is seeking a Global Regulatory Project Lead based in Indianapolis, IN. In this critical role, you will guide regulatory strategy for innovative farm and companion animal products, working with key global partners and regulatory agencies like the U.S. FDA. You will...SeniorRegulatoryRelocationFlexible hours
$115.5k - $184.8k
...in Indianapolis is searching for a seasoned Environmental Lead to drive global environmental strategy and compliance. This role requires 1... ...Bachelor’s degree and possess strong project management and regulatory skills. Excellent compensation range of $115,500 to $184,80...SeniorRegulatory- ...the Formulations Senior Research Scientist... ...biopharmaceutical portfolio for global markets. You will... ...covering Elanco’s biologics portfolio,... ...proteins, and vaccines. The role focuses... ...capabilities, and leading the technical transfer... ...and global regulatory submissions. Provide...SeniorRegulatorySummer workRelocationFlexible hours
- About the Role As a Senior Packaging Engineer - Drug... ..., you will lead the design, development... ...supporting Elanco’s global pipeline. This role focuses... ...focuses on pharmaceutical, biologics, and vaccine products, partnering... ..., Quality, and Regulatory to bring therapies from...SeniorRegulatorySummer workRelocationFlexible hours
- Elanco in Indianapolis seeks a Senior Packaging Engineer for Drug Product Development. You will lead design and implementation of packaging solutions, ensuring compliance with GMP and regulatory standards while collaborating across R&D, Manufacturing, and Regulatory teams...SeniorRegulatoryRelocation
$162k - $237.6k
Sr. Director - Global Regulatory Lead - Neuroscience/Immunology Join to apply for the Sr. Director - Global Regulatory Lead - Neuroscience/Immunology... ...for people around the world. Purpose The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (...SeniorRegulatoryFull timeWork at officeLocal areaRemote workFlexible hours- Your Role: Global Quality Auditor Lead As a Global Quality Auditor Lead, you will be part of the Elanco... ...internal sites, comply with global regulatory expectations, Elanco’s quality... ...equivalent work experience) in physical or biological sciences, engineering, or other...RegulatoryContract workWork experience placementSummer workRelocation
- ...all starts with animals! As a global leader in animal health, we... ...Role: Global Quality Auditor Lead As a Global Quality Auditor Lead... ...sites, comply with global regulatory expectations, Elanco’s quality... ...experience) in physical or biological sciences, engineering, or other...RegulatoryContract workWork experience placementSummer workRelocationFlexible hours
- ...Elanco Tiergesundheit AG is seeking a Sr Scientist - Global Regulatory Project Lead in Indianapolis, IN. This role involves guiding regulatory strategy and leading submissions for farm and companion animal products. The ideal candidate will have over 10 years of experience...RegulatoryRemote work
- A leading pharmaceutical company based in Indianapolis is seeking a Senior Director for Global Regulatory Affairs to develop regulatory strategies in neuroscience and immunology. The ideal candidate will have extensive experience in regulatory affairs, a proven leadership...RegulatoryFull time
$129k - $209k
...around the world. We are a global healthcare leader... ...the position of Advisor or Senior Advisor, Engineering, Biologics Drug Product Development.... ...validation as well as support regulatory submission. Responsibilities... ...and capability criteria. Lead manufacturing related process...SeniorRegulatoryFull timeFlexible hours- Corteva Agriscience is looking for a Global Regulatory Project Manager (GRPM) to lead regulatory project execution and strategies. In this role, you will oversee regulatory plans from initiation through to completion, ensuring alignment across global, regional, and country...Regulatory
- 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
- Elanco is seeking a Feed Additive Regulatory Specialist in Indianapolis, IN. Hybrid work arrangements; travel 10% or less. You will lead regulatory affairs for the US feed additive portfolio... ...standards. You will collaborate with global teams, support post-approval mandates,...Regulatory
$118k - $197k
Elanco in Indianapolis, IN is looking for a Global Regulatory Project Lead to guide regulatory strategies for innovative products in the animal health sector. The role involves direct negotiations with agencies like the CVM and ensuring compliance with global regulations...Regulatory- Elanco, a leader in animal health, is seeking a Senior Director to oversee the Elanco Technology Center in Indianapolis. In this role, you will lead the biologics and fermentation development teams, focusing on product lifecycle management and process optimization. The...SeniorFlexible hours
- ...where every voice matters. The Position The Global Supply Chain division operates as a vital... ...cross‑functional alignment and global regulatory compliance across R&D, Manufacturing, and... ...a Global Product Launch and Supply Chain Lead to manage organization‑wide integration...RegulatoryImmediate start
- A leading pharmaceutical company in Indianapolis is seeking an experienced Advisor/Senior Advisor in Analytical Chemistry to lead the development of antibody-drug conjugates... ...requires strong analytical expertise, regulatory compliance knowledge, and the ability to collaborate...SeniorRegulatory
- A leading life-science solutions provider in Indianapolis is looking for a Quality Operations lead. The role involves overseeing quality systems, managing compliance with regulatory standards, and driving continuous improvement initiatives. The ideal candidate will have...SeniorRegulatoryFull time
$93k - $118k
...specialist in Carmel, Indiana, focused on CIP compliance and cybersecurity initiatives. The ideal candidate will lead compliance investigations and manage regulatory training while ensuring effective risk management practices. The selected candidate should possess a...SeniorRegulatory- Syner-G is seeking a Sr. Manager to lead HVAC, facility, and CQV initiatives in GMP environments. You will manage cross‑functional... ...drive complex projects from planning through closeout, and ensure regulatory alignment. Travel to client sites may be required up to 100%...SeniorRegulatory
- Community Health Network in Indianapolis is seeking a Research Regulatory Coordinator. The role involves leading regulatory activities for clinical trials, ensuring compliance with institutional policies and regulations. Candidates should have at least 3 years of research...SeniorRegulatory
- CLS Labcorp Central Laboratory Services Limited Partnership is looking for a Lead Compliance Auditor in Indianapolis, IN, to ensure adherence to global regulatory standards and best practices in clinical research laboratory operations. This role involves managing internal...SeniorRegulatory
- Your Role As Associate Director, Regulatory Affairs - Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation. This... ...Manufacturing, Quality, Technical Operations, and global regulatory stakeholders. The ideal...RegulatorySummer workRelocationFlexible hours
- A leading financial institution is seeking a Senior Home Lending Advisor in Greenwood, Indiana. This role involves guiding clients through the mortgage process... ...of local real estate markets and adherence to regulatory guidelines. Join a dynamic team that offers considerable...SeniorRegulatoryLocal area
$200k - $240k
...Job Summary Senior Director of Global Commercial Sales and Marketing (Cell and Gene Therapy Technologies... ...Director will be responsible for leading the global commercial operations and... ...adoption. Partner with R&D, Operations, and Regulatory teams to ensure alignment between...SeniorRegulatoryPermanent employmentTemporary work- ...the Formulations Senior Research Scientist... ...biopharmaceutical portfolio for global markets. In this... ...covering Elanco’s biologics portfolio,... ...proteins, and vaccines. A key focus is the... ...capabilities and leading the technical transfer... ...portion of global regulatory submissions. This...SeniorRegulatoryContract workSummer workRelocationFlexible 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
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