Global Regulatory Lead: Strategy & FDA Affairs
BioSpace
Lilly in Indianapolis, IN is seeking a Global Regulatory Lead (GRL) to drive global regulatory strategies from entry through end of life. You will lead the Global Regulatory Team, interact with the US FDA, and align affiliate plans with global priorities to enable successful registrations. Minimum qualifications include an advanced scientific degree with 8+ years in regulatory affairs or a bachelor’s/masters with 10+ years. Travel ~10–15% is anticipated. #J-18808-Ljbffr BioSpace
$169.5k - $248.6k
...join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the... ...execution of global regulatory strategies— from portfolio entry through... ...interaction strategy with the US FDA.Key... ...of experience in regulatory affairs and/or drug developmentORBachelor...RegulatoryLocal areaFlexible hours- Lilly in Indianapolis, Indiana, is seeking a Global Regulatory Lead to guide global regulatory strategies and oversee FDA submissions from early development through lifecycle... ...scientific degree with 8+ years in regulatory affairs or equivalent experience, strong leadership,...Regulatory
- ...headquartered in Indianapolis, Indiana, seeks a Global Regulatory Lead to develop and execute global regulatory strategies and to own interactions with the US FDA. You will lead a cross-functional... ...degree with 8+ years in regulatory affairs or a Bachelor's/Master's with 10+...Regulatory
- ...Lilly and Company is seeking a Global Regulatory Lead to oversee the development... ...of global regulatory strategies from portfolio entry through... ...functional team and manage US FDA interactions, shaping development... ...with 8+ years in regulatory affairs or drug development, plus...Regulatory
- ...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... ..., and manage interactions with the US FDA. Responsibilities include developing innovative...RegulatoryLocal area
- Lilly in Indianapolis is seeking a Global Regulatory Lead to steer global regulatory strategies from portfolio entry through end of lifecycle. You will build and lead... ...addressing regulatory hurdles. You will oversee US FDA submissions and interactions, ensure alignment of...Regulatory
- Roche seeks a Senior Regulatory Affairs leader to guide the Endocrinology and Fertility... ...10-15 staff, engage with FDA and international regulators, and drive regulatory strategy and process standardization.... ...and ensure compliant global submissions across multiple regions...Regulatory
- Lilly, headquartered in Indianapolis, Indiana, seeks a Global Regulatory Lead to drive global regulatory strategy from entry to end of life and to provide strategic/... ...to a cross-functional team, including the US FDA interaction plan. You will oversee US FDA submissions...Regulatory
- ...Clinical Chemistry II Subchapter lead within the Medical Value Assays Regulatory Affairs Leadership Team. You will guide regulatory strategy and engage with FDA, Notified Bodies, and international... ...advance project objectives. This global role supports Roche Diagnostics...Regulatory
- Lilly is seeking a Global Regulatory Lead (GRL) to own global regulatory strategies from entry through end of life. You will lead a cross-functional Global Regulatory Team and manage the US FDA relationship, shaping development plans and regulatory submissions. This role...RegulatoryRelocation package
- Roche in Indianapolis is seeking a Core Lab Network Lead to join the Regulatory Affairs Leadership Team. You will translate customer and... ...solutions. You will apply VACC principles to develop global regulatory strategies, oversee resource planning, and mentor squads to balance...Regulatory
$118k - $197k
...with animals!As a global leader in animal health... ...Your Role: Global Regulatory Project LeadAs the... ...Project Lead, you will be a key... ...guiding the regulatory strategy for novel farm and... ...primary focus on CVM/FDA submissions.Serve... ...direct regulatory affairs experience in...RegulatoryFull timeSummer workLocal areaRemote workRelocationFlexible hours- Roche seeks a Regulatory Affairs leader to guide the Endocrinology and Fertility subchapter within Medical... ...will mentor 10-15 staff, act as SME to US FDA and international bodies, and drive regulatory strategies across global projects. Based in a global role with travel...Regulatory
- 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... ...substantial experience in regulatory affairs or drug development. This position...RegulatoryRelocation package
$111.2k - $258.7k
...Clinical Chemistry II Subchapter lead in the Medical Value Assays... ...of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT).... ...subject matter expert with the US FDA, Notified Bodies,... ...objectives. You monitor the global regulatory environments, and...RegulatoryFull timeLocal areaRelocation package$177k - $308k
...around the world. We are a global healthcare leader... ...using its innovation-based strategy to discover, develop... ...& Technology Strategy Lead who will define and implement... ...scientific rigor, regulatory defensibility, and meaningful... ...Statistics, Regulatory Affairs) to ensure seamless AI...RegulatoryFlexible hours- Roche, a global leader in diagnostics, seeks a Core Lab Network Lead to drive regulatory strategies and submissions across the Core Lab portfolio. You will translate customer needs into priorities and work with Functional Partners and Squads to deliver high-quality dossiers...Regulatory
- ...Vice President of Regulatory Affairs, Founding Regulatory Leader, Ophthalmology & Retina... ...take on a founding role in building and leading its global regulatory function. This senior leadership... ...and executing the global regulatory strategy, serving as the primary regulatory...Regulatory
- ...is seeking a Feed Additive Regulatory Specialist in Indianapolis,... ...travel 10% or less. You will lead regulatory affairs for the US feed additive portfolio... ...activities with FDA/USDA and ensuring all submissions... .... You will collaborate with global teams, support post-approval...Regulatory
- Roche in Indianapolis is seeking an experienced regulatory affairs professional to register and support regulatory activities for in vitro diagnostic products across global markets. You will collaborate with researchers, clinicians, and manufacturing teams to ensure compliance...Regulatory
- Elanco is seeking a Senior Scientist, Global Regulatory Lead (Project Management) to guide regulatory strategy for novel farm and companion animal products. You will serve as the regulatory expert on global teams, shaping development from inception and negotiating with...Regulatory
- 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
- American Municipal Power, Inc. seeks a Director of MISO Regulatory Affairs to lead engagement with MISO stakeholders, shape regulatory strategy, and coordinate with AMP SMEs and Legal. This senior role oversees regulatory analysis, policy interpretation, and coalition building...Regulatory
$148.5k - $257.4k
...people around the world. We are a global healthcare leader... ...strategic, tactical and operational regulatory CMC leadership across therapeutic... ...of innovative regulatory strategies and platform approaches based... ...or product lifecycle planning.Leads preparation, critical review,...RegulatoryRemote workRelocation packageFlexible hours$148.5k - $257.4k
...strategic, tactical, and operational regulatory CMC leadership across... ...strong working knowledge of global regulations, guidelines, and... ...characterization, and control strategies).Knowledge of global CMC regulatory... ...and lifecycle planning.Lead preparation, critical review,...RegulatoryFlexible hours- ...Holding AG in Indianapolis seeks a Lab Coagulation and Clinical Chemistry II Subchapter lead to guide regulatory capabilities and staff development. You will coordinate with global regulators and drive strategic regulatory initiatives across the subchapter to meet network...Regulatory
$165k - $290.4k
...around the world. We are a global healthcare leader... ...Health Global Medical Affairs, CV Outcomes/NILEX HEOR... ...Real World Evidence (RWE) strategy and implementation with... ...The Senior Director will lead and develop research... ...collaboration with medical, PRA, regulatory, LVA, LCCI, etc. to...RegulatoryFull timeFlexible hours- The Global Herbicide Resistance Leader is the subject matter expert... ...innovations. This role leads global resistance management... ...insights, and develops sustainable strategies that protect product... ...response processes.Contribute to regulatory and scientific documentation...RegulatoryLocal area1 day per week
- ...seeking a Lab Coagulation and Clinical Chemistry II Subchapter lead in the Medical Value Assays Regulatory Affairs Leadership Team. You will oversee 10-15 Regulatory Affairs staff, coordinating with US FDA, EU Notified Bodies and other international bodies to advance project...Regulatory
- Roche Holding AG is seeking a Supply Chain Science & Technology Lead (Reagents) in Indianapolis. You will drive stability, global regulatory compliance and scalable operations for biochemical products across the end-to-end supply chain, partnering with R&D, Manufacturing...Regulatory
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