Remote US Regulatory Lead: FDA Submissions & Strategy
Ledgent Technology
- Remote job
Ledgent Technology, a division of Roth Staffing, seeks a US Regulatory Lead for a 6-month contract in Boston, MA. The role focuses on FDA submissions (IND/NDA/BLA) and regulatory strategy, with 7-10 years of US regulatory affairs experience. It is a remote, W2 hourly position with limited travel. Responsibilities include preparing for FDA meetings, regulatory intelligence, and cross-functional collaboration to support product development and launches. #J-18808-Ljbffr Ledgent Technology
- Orchard Therapeutics is seeking a US Regulatory Lead to drive regulatory strategy and execution for ex-vivo gene therapy programs. This role reports to the... ..., and a regulatory certification. This role offers remote work with a US market focus and comprehensive benefits...Remote workRegulatory
- ...Medicine, Inc. is seeking a Sr Regulatory Affairs Specialist to support regulatory submissions and health authority... ...companion diagnostic products in the US. This role develops regulatory strategy and prepares submission packages for FDA approvals, collaborating with...Regulatory
- ...Venesco, LLC is seeking a Senior Regulatory Affairs Scientist to lead submission strategies and regulatory interactions for innovative medical products. This full... ...affairs experience and a strong grasp of FDA regulations and ICH guidelines. Responsibilities include...RegulatoryFull time
$169.5k - $248.6k
...invite you to join us. About the RoleAs the Global Regulatory Lead (GRL), you will be... ...global regulatory strategies— from portfolio... ...strategy with the US FDA.Key... ...OversightOversee all US FDA submissions and agency interactions... ...is provided, remote is not available for...Remote workRegulatoryLocal areaRelocationFlexible hours- ...Scientific Ltd seeks an experienced Global Regulatory Lead to cover medical leave and lead regulatory strategy for cardiovascular programs globally. The role includes US leadership, cross-functional alignment, and NDA submission preparation. The successful candidate will...Remote jobRegulatory
- ...is seeking a Senior Regulatory Project Manager to transform strategy into action,... ...development and global submissions. You will partner with... ...Global Regulatory Leads, manage complex programs... ...excellence across US and international... ...governance, with remote work options from Canada...Remote jobRegulatory
Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid). You will develop and execute regulatory... ...strategy and tactics for US/Canada, coordinating with FDA to ensure timely filings and inspections and enabling...
Regulatory- AbbVie seeks a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy. The role involves shaping regulatory plans, interfacing with FDA, coordinating submissions, and guiding cross-functional teams to ensure compliant commercialization. The position...Regulatory
- AbbVie seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) to lead regulatory strategy development and execution for US and Canada products. You will coordinate with FDA, support filings, and advise cross-functional teams on regulatory issues...Regulatory
- ...States is seeking a Senior Manager Regulatory Affairs, Global Regulatory Strategy US & Canada, hybrid work arrangement.... ...and lifecycle management. You will lead cross-functional teams, prepare regulatory submissions, and support FDA interactions. #J-18808-Ljbffr AbbVieRegulatory
- AbbVie is seeking a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy and execution for on-market products or those in development. You... ...communication skills, experience with regulatory submissions, and the ability to operate in a complex matrix...Regulatory
- ...Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US. Applicants should have a Bachelor's...Regulatory
- AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Immunology) to lead regulatory planning and execution for on-market... ...cross-functional teams, interfaces with FDA, and ensures timely submissions, responses, and alignment with QDP; a...Regulatory
$182.1k - $338.3k
...healthier future. It’s what drives us to innovate. To continuously... ...Content & Evidence Submission Strategy Lead is focused on developing the... ...interpret external legal and regulatory landscapes, and lead cross-functional... ...guidelines, US Regulatory/FDA requirements, and drug...RegulatoryFull timeLocal area- AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device to develop and execute regulatory strategies for on... ..., and guide cross-functional teams to ensure timely submissions and compliant regulatory outcomes. The role requires...Regulatory
- Stryker Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. This fully remote position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field. Candidates should have extensive...Remote jobRegulatory
- ...seeks an experienced Regulatory Manager to plan and... ...regulatory submissions across clinical, non... ...CMC areas. You will lead authoring and preparation... ...teams, and guide strategy and tactics for submissions in the US and abroad. The role... ...knowledge of FDA/ICH guidance, CTD/eCTD...Regulatory
- AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device to shape regulatory strategy for on-... ...development programs, coordinating US/Canada submissions and interactions with FDA. You will drive lifecycle activities, lifecycle...Regulatory
- ...SARL is seeking a Senior Director of US Regulatory Strategy in Boston to lead regulatory guidance for biotech and... ...strategic oversight of BLA submissions, with a focus on complex biologics... ...will have extensive experience in FDA regulatory strategy, particularly for...Regulatory
$190k - $240k
Orchard Therapeutics - U.S. is seeking a Regulatory Science expert to lead US regulatory strategy for gene therapy. The role involves collaboration with global teams to expedite FDA submissions while ensuring compliance across clinical development. Candidates should have...Regulatory- ...about AbbVie, please visit us at . Follow @abbvie on... ...The Senior Manager, Regulatory Affairs US & Canada Strategy Lead is responsible for the development... ...and interfaces with FDA for meetings,... ...and review of regulatory submissions consistent within US and...RegulatoryFull timeLocal area
- ...A leading life sciences company is seeking a Regulatory Operations Manager to oversee the publishing of deliverables for electronic submissions to health authorities. The role involves vendor... ..., particularly in the US and Europe. This is a remote position requiring expertise...Remote workRegulatory
$185k - $210k
...culture at Sobi North America get us excited to come to work... ...Description The US Regulatory Strategy lead is responsible for all aspects... ...team for any major FDA Meetings and leads/facilitates... ...Response to FDA Contributes to Submission Taskforce meeting and efforts...RegulatoryOdd jobFull timeTemporary workWork experience placement- Solventum, a new healthcare company, seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for the Dental Solutions portfolio across global... ..., Canada, and the EU. You will guide regulatory strategy, coordinate lifecycle activities, review labeling,...Remote jobRegulatory
$170.45k - $243.5k
...impact.Purpose & Scope The Lead (Director), Medical Value Evidence (MVE), MA-US is accountable for... ...create and execute US MVE strategies and tactics within... ...commercial functions and Regulatory Affairs to identify collaborative... ...Northbrook, Illinois. Remote work from anywhere in...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide$161.93k - $281k
Job DescriptionMedical Lead Oncology, MA-US (NSCLC)About Astellas Astellas... ...of medical and scientific strategies for one or more products within... ...strategy Collaborate with Regulatory Affairs and... ...based in Northbrook, Illinois. Remote work from anywhere in the US...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide- Parexel is seeking a Regulatory Strategy Consultant to lead regulatory strategy across major programs in a remote capacity in the United States. You will shape regulatory pathways... ...planning, and drive high-impact submissions with cross-functional teams. The role requires...Remote jobRegulatory
$161.93k - $243.5k
...DescriptionSetidegrasib Launch Lead (NSCLC), US OncologyAbout Astellas... ...leading U.S. commercial launch strategy and execution readiness for... ...partnership with medical, legal, regulatory, market access, sales,... ...based in Northbrook, Illinois. Remote work from anywhere in the US...Remote workRegulatoryWork at officeWork from homeWorldwideFlexible hours- ...Corporation is seeking a senior Regulatory Affairs leader to... ...champion regulatory strategy across Latin America.... ...ANMAT to influence submissions and timelines, ensuring... ...product goals. You will lead a regional regulatory... ...and Commercial teams. Remote home office with 15-25...Remote jobRegulatoryHome office
$154.4k - $242.55k
...Brand Insights and Analytics Lead, US Oncology is an Associate Director... ...and execution of brand strategies that drive brand awareness, market... ...simultaneouslyKnowledge of regulatory requirements and compliance... ...accordance with Takeda's Hybrid and Remote Work policy. #LI-HybridTakeda...Remote workRegulatoryMinimum wageTemporary workLocal area
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