Regulatory & Clinical Strategy Lead — Remote
ZEISS Meditec Inc.
- Remote job
ZEISS Meditec Inc. is seeking a Senior Advisor, Regulatory and Clinical Affairs, US, to guide regulatory and clinical strategies for efficient US market approvals of CZM products. You will lead FDA submissions (510(k)s, PMAs, IDEs) and shape global clinical studies, collaborating with product development and US teams. The role requires deep FDA regulatory knowledge, leadership in ophthalmic device standards, and the ability to train internal teams on US requirements. #J-18808-Ljbffr ZEISS Meditec Inc.
- ZEISS Meditec Inc. is seeking a Senior Advisor, Regulatory and Clinical Affairs, US, to guide regulatory and clinical strategies for a broad US portfolio. You will oversee... ...standards development for ophthalmic devices. Remote role with significant leadership...Remote jobRegulatory
- ZEISS Meditec Inc. is seeking a Senior Advisor for Regulatory and Clinical Affairs. This remote role demands an expert to guide regulatory strategies and oversee FDA submissions for the U.S. market. Ideal candidates will have significant experience in FDA regulations and...Remote jobRegulatory
$183k - $228.8k
A leading medical technology company is seeking a Senior Advisor for Regulatory and Clinical Affairs to guide strategies in the commercialization of medical devices in the US. The role requires expertise in FDA submissions and the design of clinical research studies. Candidates...Remote jobRegulatory- ...United States is seeking a Clinical Content & Editing Reimbursement Manager to lead the development and... ...provider reimbursement strategies. This hybrid role blends... ...collaboration with remote flexibility, supporting payment accuracy, regulatory compliance, and cost‑of...Remote workRegulatoryWork at office
- ...seeking a Senior Manager, Clinical Trials to own the strategy for late-phase studies while... ...8+ years of experience leading Phase 3 trials, with in-depth... ...GCP, ICH guidelines, and regulatory submissions. This hybrid role allows for 3 days of remote work. #J-18808-Ljbffr...Remote workRegulatory
- ...in the United States seeks a Senior Advisor of Regulatory and Clinical Affairs to guide regulatory and clinical strategies for CZM's US market, ensuring timely, compliant... ...commercialization of ophthalmic medical devices. You will lead FDA submissions (510(k), PMA, IDE), advise on...Regulatory
- Elevance Health is seeking a Clinical Content & Editing Reimbursement Manager to lead the development and execution of clinical content and provider reimbursement strategies that support payment accuracy, regulatory compliance, and cost-of-care initiatives. The role requires...Regulatory
- ...a Site Team Leader to oversee clinical trial sites across the region from... ..., within budget, and in full regulatory compliance. You will coach site... ...staff, review performance metrics, lead monthly business reviews, and drive enrollment strategies while maintaining high quality...Remote jobRegulatory
$148.3k - $241.9k
...Senior Manager Clinical Study Lead (Hematology) 2 days ago Be among the first... ...office locations. Fully remote is not eligible. The Senior... ...identifies risk mitigation strategies at the study level Leads the... ...Knowledge of ICH/GCP and regulatory guidelines/directives Advanced...Remote workRegulatoryWork at office- ...seeking a senior professional for Enterprise Clinical to build and scale global clinical operations.... ...while protecting patient safety, quality, and regulatory standards. You will partner with Clinical, Enterprise Strategy, Global Talent, Legal, Compliance, HR, Talent...Regulatory
- The Cigna Group seeks a seasoned leader to drive global clinical strategy, coordinating hub scope, operating models, and governance across legal, regulatory, and client requirements. You’ll translate roadmaps into action, manage multiple workstreams, and surface risks...Regulatory
- ZEISS Meditec Inc. in the United States seeks a Senior Advisor, Regulatory and Clinical Affairs to guide regulatory and clinical strategies for its ophthalmic portfolio in the US. You will lead FDA submissions (Q-sub, 510(k), PMA, IDE) and design clinical studies that support...Remote jobRegulatory
- Daiichi Sankyo, Inc. seeks a senior clinical development leader to oversee global programs and lead regulatory strategy across multiple Phase II/III studies. You will ensure CRO performance and provide medical input into submissions, translational medicine, and biomarker...Regulatory
- Humana Inc. seeks a Nurse Clinical Lead to guide clinical strategy for Medicare Stars, Risk Adjustment (MRA), and Interoperability. You will leverage clinical... ...the Quality and Cost Strategy organization. This is a remote, high-impact leadership position within Humana. #J-188...Remote work
- ...continue to grow stronger every day. Position Overview: The Clinical Strategy Lead is responsible for developing and executing clinical... ...the product lifecycle. This role partners Clinical Affairs, Regulatory Affairs, R&D, Marketing, and Medical Affairs to identify evidence...RegulatoryContract work
$161k - $258k
...A leading fintech firm is seeking a Head of Licensing to drive its regulatory licensing strategy across the U.S. and international markets. The ideal candidate will have at least 10 years of regulatory licensing experience and a strong understanding of U.S. financial...Remote workRegulatory- ...Durham, NC is seeking an Associate Clinical Safety Surveillance Director to lead SAE/AESI oversight across UTC... ...days, leading safety governance, strategy, and compliance initiatives global... ...ensure robust safety data handling and regulatory compliance across developmental programs...RegulatoryWork at office
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy responsible for developing and executing regulatory strategies for Phase 2 and Phase 3 programs. This role requires extensive interaction with FDA and global health authorities. Ideal candidates will...Remote jobRegulatory
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute regulatory strategies for clinical programs. This role requires 10+ years of... ...successful registration of investigational products, leading major regulatory initiatives and acting as...Remote jobRegulatory
- Travere Therapeutics is seeking a Director, Regulatory Affairs Strategy to develop and execute global regulatory strategies for Phase 2 and Phase 3 programs. You will work closely with teams to ensure compliance and strategic alignment with regulatory bodies. The ideal...Remote jobRegulatory
$189k - $246k
Travere Therapeutics is looking for a Director of Regulatory Affairs Strategy to develop and execute regulatory strategies for Phase 2 and Phase 3 development programs. This role involves close collaboration with cross-functional teams and requires significant experience...Remote jobRegulatory- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy based in Washington, DC, to develop and execute global regulatory strategies for late-stage clinical programs. This role involves leading regulatory submissions and engaging with health authorities...Remote jobRegulatory
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute global regulatory strategies for Phase 2 and Phase 3 clinical development programs. This role involves close collaboration with Clinical Development and other teams to drive...Remote jobRegulatory
$80 - $90 per hour
Remote - Regional Clinical Operations Lead • A highly reputable biotechnology corporation is currently hiring a... ...Science, Clinical Data Management, Regulatory, Biostatistics, Pharmacology and... ...study risks, recommend mitigation strategies/solutions and facilitate discussions...Remote jobRegulatoryContract workCurrently hiring$174k - $212k
...looking for an experienced Associate Director of Clinical Data Management to guide the clinical data strategy for gene editing programs. This role will involve overseeing data management activities to ensure regulatory compliance and clinical data integrity. The ideal...Regulatory- ...Associate Director, FSP Clinical Operations is... ...short- and long-term strategies. Develop and manage communication... ...associated data. Lead Client-specific FSP meetings... ..., clients, and regulatory agencies as necessary.... ...experience working in a remote office environment and...Remote workRegulatoryTemporary workFor subcontractorLocal areaFlexible hours
- ...Director, Medical Writing to join their team remotely in the United States. This role involves supporting major regulatory submissions and providing strategic leadership... ...a balance of hands-on writing and broader submission strategies. #J-18808-Ljbffr Barrington JamesRemote jobRegulatory
$137.8k - $206.8k
...Description The Senior Manager, Clinical Study Quality Lead provides study-level... ...including risk-based audit strategy, quality risk... ...not eligible for a fully remote work arrangement. Key Duties... ...clinical programs. Support regulatory agency inspections at Vertex...Remote workRegulatoryFlexible hours2 days per week- Parexel is seeking a Senior / Vice President, Technical to lead its Regulatory Science team. You will influence clinical development strategies for top biopharma clients while ensuring regulatory compliance. Ideal candidates possess 15+ years in clinical trial design and...Remote jobRegulatory
$189k - $246k
...Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute comprehensive regulatory strategies supporting clinical development and commercialization of investigational... ...with cross-functional teams and leading regulatory submissions for pivotal...Remote jobRegulatory
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