Senior Director, Clinical Affairs — Regulatory Strategy
Sysmex America, Inc
Sysmex America, Inc. in Lincolnshire, IL is seeking a Senior Director, Clinical Affairs to lead the clinical strategy for Sysmex IVD products. You will direct preclinical and clinical evaluation plans, ensure FDA and CLSI guideline compliance, and oversee IRB-approved studies in the RACA Laboratory, collaborating with external institutions. The ideal candidate has 15+ years in clinical research with 8+ years leading programs, strong regulatory knowledge, and excellent leadership and #J-18808-Ljbffr Sysmex America, Inc
- ...Corporation in Lincolnshire, Illinois, is seeking a Director of Clinical Affairs to develop and execute clinical strategies for new and modified IVD products. You will... ...high-quality clinical documentation and regulatory submissions. #J-18808-Ljbffr Sysmex CorporationRegulatory
- Sysmex America, Inc is seeking a Director, Clinical Affairs in Lincolnshire, IL. This senior role develops and executes the clinical strategy for Sysmex IVD products and acts as Principal... ...to drive clinical programs and regulatory submissions. The candidate will lead...Regulatory
$210k - $330k
...and life sciences for the clinical laboratory....to build a... ...opportunity available for a Senior Director, Clinical Affairs. The Senior Director,... ...and executing the clinical strategy for new and modified... ...other necessary clinical/regulatory documentation. Mentor and...SeniorRegulatoryWork at officeWorldwide- ...AbbVie is seeking a Senior Medical Director/Scientific Director to provide... ...medical input into medical affairs strategy, data generation, education... ...partners with Commercial and Regulatory teams to support product... ...in Medical Affairs and clinical development is required, along...SeniorRegulatory
- ...AbbVie's medical affairs organization provides... ...everywhere with practical and clinically relevant information... .... The Scientific Director / Senior Medical Director... ...global medical affairs strategy, driving scientific excellence... ...Commercial, HEOR, Regulatory, Clinical Development...SeniorRegulatoryWork at office3 days per week
- ...Description The Scientific Director / Senior Medical Director... ...operational medical affairs activities such as:... ...; generation of clinical and scientific data (... ...core brand (product) strategies, and to support medical... ...Clinical Study Reports, and Regulatory Submissions and...SeniorRegulatoryTemporary workLocal area3 days per week
- ...Job Description The Senior Medical Director/Scientific Director, Medical Affairs provides specialist... ...providers; generating clinical and scientific data to... ...core brand (product) strategies, and to support medical... ...Clinical Study Reports and regulatory submissions and...SeniorRegulatoryFull timeWork at officeLocal area
- ...Overview The Scientific Director / Senior Medical Director, Medical Affairs provides specialist... ...brand, and value‑and‑access strategies that meet on‑market and... ..., market access, HEOR, clinical operations, clinical development, and regulatory) to ensure broad cross‑functional...SeniorRegulatoryWork at office
- ...Description The Medical Affairs organization provides... ...with the practical, clinically relevant information... .... The Scientific Director / Senior Medical Director,... ...and value-and-access strategies that meet on-market and... ...development, and regulatory) to ensure broad cross...SeniorRegulatoryFull timeWork at officeLocal area
- ...an experienced Scientific Director or Senior Medical Director to lead the Global Medical Affairs Precision Medicine strategy across the oncology... ...across Medical Affairs, Clinical Development, Precision Medicine... ...Medicine, Commercial, HEOR, Regulatory, and International teams...SeniorRegulatoryFull timeLocal area3 days per week
- ...Description The Senior Medical Director/Scientific Director, Medical Affairs provides specialist medical... ...providers; generating clinical and scientific data to... ...core brand (product) strategies, and to support... ...Clinical Study Reports and regulatory submissions and...SeniorRegulatoryWork at officeLocal area
- ...Description The Medical Affairs organization provides... ...the practical and clinically relevant information... .... The Scientific Director / Senior Medical Director,... ...core brand (product) strategies, and to support medical... ..., statistics, regulatory, etc…) as they relate...SeniorRegulatoryWork at officeLocal area
- ...Purpose: The Senior Scientific Director / Executive Medical... ...input into core medical affairs activities such as:... ...Providers); generation of clinical and scientific data... ...brand (product) strategies, and to drive medical... ...Commercial, Market Access, Regulatory, HEOR and other...SeniorRegulatoryWork at officeLocal area
- ...Abbott Laboratories in Buffalo Grove, IL is seeking a Regulatory Affairs Specialist III to support regulatory direction for diabetes care... ...regulatory input to product teams. The role emphasizes regulatory strategy, documentation, and collaboration with cross-functional...SeniorRegulatory
- ...and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is... ...Regulatory Lead (GRL), Associate Director, or Director), in the development... ...issues including Public Affairs, Clinical Development, Legal, and others such...SeniorRegulatoryLocal area
- ...Facebook, Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device is responsible for the... ...on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial....SeniorRegulatory
- Abbott in Buffalo Grove, IL is seeking a Regulatory Affairs Specialist III to support day-to-day regulatory activities for new and existing medical devices. You will help develop global regulatory strategies, prepare US submissions, and ensure compliance with GMP and quality...SeniorRegulatory
$165k - $185k
...the United States SUMMARY: The Senior Manager, Regulatory Strategy (US RA): supports the creation and... ...regulatory perspective at Regulatory Affairs Focus Team (RAFT) meetings. Identifies... ...US regulatory requirements for clinical studies and marketing. Assesses scientific...SeniorRegulatoryWork at officeRemote workFlexible hours- ...AbbVie is seeking an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to partner with internal and external... ...deliver products to patients. You will develop regulatory strategies for CMC to enable first-pass approvals and manage content...SeniorRegulatory
- ...ICU Medical is seeking an experienced Regulatory Affairs professional to support global and US registrations for device products. You will analyze requirements, create regulatory strategies, and maintain dossiers with oversight. Ideal candidates have 7+ years in medical...SeniorRegulatory
- Hybrid Senior Manager, Regulatory Affairs About the job Hybrid Senior Manager, Regulatory Affairs Introduction... ...analysis, and life sciences for the clinical laboratory. Responsibilities We... ...role involves leading the regulatory strategy for new and modified medical device...SeniorRegulatoryWork at officeWorldwide
$224k - $308k
.... Your Role at Baxter:The Senior Director, Clinical Research - Infusion Therapies... ...evidence-generation strategies across Baxter's ITP portfolio... ...partnership with Medical Affairs, the Senior Director translates... ..., product development, regulatory submissions, post-market...SeniorRegulatoryFull timeTemporary workFlexible hours- ...Nutrien Ag Solutions Limited is seeking an Sr Specialist, Regulatory - Fertilizer & Plant Nutrition to manage state registrations and... ...fertilizers and plant nutrients. You will coordinate with Regulatory Affairs, Product Development, Legal, Manufacturing, Customer Service,...SeniorRegulatory
$295k - $335k
...journey of growth! The Sr. Director, Medical Affairs Rare Neurology within US... ...System Atrophy (MSA) strategies with the needs of patients... ...Commercial, Market Access, Regulatory, Clinical Development, Pharmacovigilance... ...planning. ~ Served as senior medical reviewer for...SeniorRegulatoryFull timeWork at officeRemote workFlexible hours- Fresenius Kabi USA in Lake Zurich, IL, seeks a Senior Manager, Regulatory Affairs to lead regulatory decision making for complex products, guiding... ...position collaborates with regulatory agencies to align strategies with business objectives and drive successful submissions...SeniorRegulatoryRemote work3 days per week
- Fresenius Kabi in Lake Zurich, IL is seeking a Senior Manager, Regulatory Affairs to shape regulatory strategy for complex products. This senior IC will approve strategies, guide execution, and lead cross-functional teams on high-risk submissions. The role requires extensive...SeniorRegulatory3 days per week
- Astellas Pharma in Northbrook, IL, seeks a Regulatory Affairs professional to develop regulatory strategy for new assignments, including NDA planning, with management oversight and submission execution. You will coordinate with FDA and global health authorities, and lead...SeniorRegulatory
- Lundbeck seeks a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies. You will drive... ...FDA and ex-U.S. health authorities. Partner with R&D, Clinical, Commercial, and Legal & Regulatory Compliance to ensure...SeniorRegulatory
- ICU Medical seeks a seasoned Regulatory Affairs professional to provide global and US registration expertise for electro-mechanical device... ...dossiers, ensure documentation compliance, and support regulatory strategy with cross-functional teams. You will liaise with regulatory...SeniorRegulatory
- Fresenius Kabi USA in Lake Zurich, IL seeks a Senior Manager of Regulatory Affairs to drive regulatory decision‑making and strategy for complex products, lead cross‑functional teams, and ensure lifecycle compliance across markets. This onsite role requires 3 days per week...SeniorRegulatoryRemote work3 days per week
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