Global Regulatory Lead: Strategy & FDA Partnerships
Eli Lilly and Company
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 with the US FDA. Responsibilities include developing innovative regulatory strategies, overseeing INDs, NDAs, and BLAs, and ensuring alignment of local affiliate plans with global strategy. #J-18808-Ljbffr Eli Lilly and Company
- Your Role: Global Quality Auditor Lead As a Global Quality Auditor Lead... ...comply with global regulatory expectations, Elanco... ...compliance strategy, quality oversight,... ...evaluations for new partnerships and acquisitions What... ...manufacturing platforms under FDA, EMA, or similar...PartnershipRegulatoryContract workWork experience placementSummer workRelocation
- ...with animals! As a global leader in animal... ...Global Quality Auditor Lead As a Global... ...comply with global regulatory expectations, Elanco... ...compliance strategy, quality oversight... ...evaluations for new partnerships and acquisitions.... ...manufacturing platforms under FDA, EMA, or similar...PartnershipRegulatoryContract workWork experience placementSummer workRelocationFlexible hours
$115.5k - $184.8k
...Indianapolis is searching for a seasoned Environmental Lead to drive global environmental strategy and compliance. This role requires 10+ years in... ...Bachelor’s degree and possess strong project management and regulatory skills. Excellent compensation range of $115,500 to $...Regulatory$118k - $197k
Global Regulatory Project Lead As the Global Regulatory Project Lead, you will be a key individual contributor... ...pipeline, guiding the regulatory strategy for novel farm and companion animal... ...projects, with a primary focus on CVM/FDA submissions. Serve as the dedicated...RegulatorySummer workLocal areaRemote 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
- ...Agriscience is seeking an experienced Global Regulatory Project Manager (GRPM) to join our dynamic... ...Manager (GRPM) translates regulatory strategy and plans into actionable execution by... ...Interactions The GRPM works in close partnership with regulatory affairs and regulatory...PartnershipRegulatory
- Lilly, headquartered in Indianapolis, IN, seeks a Regulatory CMC leader to guide biologics development and global submissions. You will apply deep regulatory... ...leadership, and excellent communication skills to drive strategies across geographies. #J-18808-Ljbffr BioSpaceRegulatory
- 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
$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 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... ...regulatory agencies like the U.S. FDA. You will leverage 10+ years of...RegulatoryRelocationFlexible hours
$169.5k - $248.6k
Eli Lilly and Company, based in Indianapolis, seeks a Senior Director for Global Regulatory Affairs. The role involves developing and implementing regulatory strategies for product cycles, leading a diverse team, and ensuring compliance across global markets. Candidates...Regulatory$121.5k - $198k
...Advisor - Inspection Lead role at BioSpace 1... ...world. We are a global healthcare leader... ...consistently prepared for regulatory inspections and... ...Readiness Strategy & Execution Lead... ...inspections. -Foster strong partnerships with ****@*****.***... ...(e.g., FDA, EMA). Strong knowledge...PartnershipRegulatoryFull timeWorldwideFlexible hours$127.5k - $187k
...around the world. We are a global healthcare leader... ...learning solutions and strategies that empower Lilly's... ...Development Build and lead a high-performing global... ...central functions, in partnership with M2 Platform Lead,... ...training gaps and regulatory expectations. Advocate...PartnershipRegulatoryFull timeH1bLocal areaVisa sponsorshipWork visaFlexible hoursShift work- ...Indiana. This role involves advising on indirect tax regulatory changes and optimizing tax strategies within a globally connected environment. The successful candidate... ...skills. You’ll also manage processes and lead teams to deliver quality solutions, traveling as...Regulatory
$162k - $237.6k
Sr. Director - Global Regulatory Lead - Neuroscience/Immunology Join to apply for the Sr. Director... ...implement innovative global regulatory strategies for product(s) in the assigned therapeutic... ..., and leverage relationships with FDA, Health Canada, team members, and partner...RegulatoryFull timeWork at officeLocal areaRemote workFlexible hours$200k - $240k
...Summary Senior Director of Global Commercial Sales and... ...'s global commercial strategy within the MedTech CGT... ...be responsible for leading the global commercial... ...research). Develop strategic partnerships, identify new business... ...R&D, Operations, and Regulatory teams to ensure...PartnershipRegulatoryPermanent employmentTemporary work- 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...RegulatoryRelocationFlexible hours
$129k - $186k
...hospital compliance with industry, regulatory and Banfield quality... ...performance expectations. In partnership with the Director of Veterinary... ...with interviews, and leading onboarding and training of new... ...operations by implementing strategies to reduce turnover risk and...PartnershipRegulatoryLocumLocal areaRelocation packageShift workAfternoon shift- ...across North America.You will lead logistics safety and... ...come from building trusted partnerships, maintaining strong regulatory and safety expertise, and... ...and drive the regional strategy to strengthen distribution... ...in partnership with the Global Risk Manager and logistics...PartnershipRegulatoryWork at officeLocal area1 day per week
- ...Collaborations in Indianapolis. This role involves leading pharmacovigilance strategy, managing alliance partnerships, and directing negotiations for business... ...pharmaceutical sector, primarily in pharmacovigilance and regulatory affairs. The position comes with competitive...PartnershipRegulatory
$115.5k - $184.8k
Initial Therapeutics, Inc. in Indianapolis seeks an experienced Global Waste Management professional to provide strategic and... ...compliance. Responsibilities include defining waste management strategies, providing technical leadership, and driving resource recovery...$286.5k - $420.2k
...around the world. We are a global healthcare leader... ...affiliate clinical research, partnerships or collaborations,... ...unit, and company strategies and are completed on time... ...GI) and Incretin GBD lead and HEOR seamless... ...as a medical expert. Regulatory/ Submission Responsibilities...PartnershipRegulatoryFull timeWork at officeLocal areaFlexible hoursShift work- MITSUBISHI HEAVY INDUSTRIES (USA) sucht in Indianapolis nach einem Vice President Marketing, der die strategische und operative Verantwortung für alle Marketingaktivitäten übernimmt. Sie entwickeln die Marketingstrategie, koordinieren Kampagnen über Märkte hinweg, führen...Partnership
$170k - $210k
...Central Laboratory Services Limited Partnership is seeking a Senior Director to... ...executing multi-year account strategies that enhance client value and governance across global programs. The successful... ...or Master’s degree. They will lead complex drug development programs...Partnership- A leading agricultural cooperative in Indianapolis is looking for a Crop Protection Procurement Lead to develop sourcing strategies for crop protection products. The ideal candidate will have a... ...managing inventory, and ensuring regulatory compliance. The company offers health...Regulatory
- Elanco is seeking a Feed Additive Regulatory Specialist in Indianapolis, IN... ...travel 10% or less. You will lead regulatory affairs for the US... ...registration activities with FDA/USDA and ensuring all... ...standards. You will collaborate with global teams, support post-approval mandates...Regulatory
- Belden in Carmel, Indiana is seeking a Security Strategy Principal to be the key technical consultant for security products. This role... ...building relationships with key partners and staying informed on regulatory standards affecting customers. #J-18808-Ljbffr BeldenRegulatory
$117k - $209k
...around the world. We are a global healthcare leader... ...appropriate product control strategies based on anticipated... ...technical, Regulatory and Quality compliance... ...Manufacturing needs. Identify and lead the deployment of new... ...as in teams. Provides partnership and collaboration...PartnershipRegulatoryFull timeFlexible hours$163.5k - $239.8k
...around the world. We are a global healthcare leader... ...and Deliverables: Lead the Global Product Steward... ..., site readiness, regulatory strategy, and capital investment... ...of building productive partnerships across organizational,... ...authorities (e.g., FDA, EMA, PMDA) during regulatory...PartnershipRegulatoryFull timeContract workTemporary workRemote workWork from homeMonday to FridayFlexible hours
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