Regulatory Strategy Specialist: Submissions & Compliance
neurocrine
Neurocrine Biosciences is seeking a Regulatory Affairs professional to coordinate submission packages for regulatory authorities, including INDs and annual reports. The role requires strong knowledge of FDA regulations, ICH guidelines, and robust project management skills. The candidate will maintain submission timelines, support strategies for earliest approvals, and collaborate with internal teams to ensure accuracy and compliance across regulatory documents. #J-18808-Ljbffr neurocrine
- Neurocrine Biosciences is seeking a regulatory submissions coordinator to prepare and manage regulatory filings for clinical trials and product registrations. You will ensure compliance with FDA/ICH guidelines, reviews, and maintains documentation across submission lifecycle...Suggested
- Dexcom Corporation is seeking a Regulatory Affairs professional to support regulatory activities for Dexcom software products and develop global regulatory strategies for submissions in the US, EU and Canada. You will collaborate with regional teams, review software labeling...SuggestedRemote job
- ...James in San Diego seeks a Regulatory Affairs Specialist/Senior Specialist to lead complex global submissions (FDA, EU Notified Bodies) and guide product lifecycle compliance in a fast‑paced diagnostics... ...translate science into regulatory strategy. You will collaborate with R...Suggested
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$71.6k - $119.3k
...health on a global scale stands before us. Meet The Team Regulatory Affairs is a team of more than 40 professionals located... ...for Dexcom software products. You will develop regulatory strategies and prepare submissions in various countries (US, EU, Canada). You will...SuggestedWork at officeRemote workWorldwideHome officeFlexible hours$110k - $125k
...Cymbiotika is seeking an experienced Regulatory Compliance Specialist to support product compliance and... ...certifications, and other regulatory submissions for applicable international markets... ...compliance matters. Support regulatory strategy for assigned projects by identifying...Remote workWork from homeFlexible hours- Regulatory Affairs Specialist/Senior Specialist We're currently supporting A global... ...systems, regulatory compliance, product development, and... ...and post-market regulatory submissions with the US FDA, Notified... ...products. Develop regulatory strategies for new product...
- Dexcom Inc. in San Diego, CA is seeking a Regulatory Affairs professional to support software product development and submissions in the US, EU, and Canada. You will partner... ...-functional teams to develop regulatory strategies and ensure compliant labeling and promotion...
- Dexcom Inc. is seeking a Regulatory Affairs Specialist to support development activities for our CGM software products and to develop regulatory strategies for submissions worldwide. You will collaborate with regional teams to align global regulatory plans and ensure labeling...Worldwide
$105.8k - $132.25k
Regulatory Affairs Specialist 3 - Medical Device IVD Location: CA-San Diego, US... ...for ensuring regulatory compliance and supporting global market... ...and executing regulatory strategies, preparing and submitting... ...post‑market regulatory submissions with the US FDA, Notified...Full timeContract workWork at officeLocal area- Senior Regulatory Affairs Specialist - Medical Devices Clinical San Diego , California... ...and U.S. medical device submissions . This individual will... ..., maintain regulatory compliance for marketed products, and... ...implementation of regulatory strategies for new and existing...Contract work
$91.7k - $137.53k
...SummaryPosition Overview: The Senior Regulatory Affairs Specialist will lead activities which support... ...international regulatory registrations and submissions activities including working with... ...Regulatory support to on-going compliance and corporate initiatives.• Partner...Full timeWork at office- ...US Regulatory Affairs LeadScope of Responsibilities:He/She will be responsible for representing regulatory function to approve promotional... ...including matters related to policy, product/project strategy, FDA engagement, labeling and advertising.Responsible for regulatory...
$90k - $95k
...questions in healthcare. Job Type: Full time Job Title: Regulatory & Compliance Specialist Location: Onsite - San Diego Salary Range: $90,000... ...and regulatory documents in support of regulatory submission (De Novo and 510K) for IVD products. Requirements...Full time- ...available in the US and around the world. Regulatory Affairs Consultant, In Silico Modeling... ...to lead the development of regulatory strategies and objectives that result in the... ...activities in support of all regulatory submissions. Serve as the primary company contact...Local areaRemote work10 hours per week
- ...of Our Clients Job Title: Regulatory Affairs Associate Duration:... ...associated with US and global submission requirements, including... ...execution of global regulatory strategies and assists in creation and... ...dossiers. Assures full regulatory compliance of all documentation for...Work at officeWorldwideHome office
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- ...Notice: Gafcon is seeking qualified Labor Compliance professionals to support both current... ...the client’s counsel for approval and submission to the appropriate government agency.Investigates... ...as part of our overall compensation strategy.Equal Employment Opportunity...For contractorsApprenticeshipLocal areaImmediate startFlexible hours
- Mission Fed Credit Union is seeking a Lending Compliance Officer in hybrid San Diego, CA entry to senior level. The role focuses on regulatory excellence across real estate, consumer, and indirect lending, guiding decisions with confidence and data-driven risk assessments...
$150k - $195k
...The Associate Director, CMC Regulatory Affairs is responsible for providing... ...of global CMC regulatory strategies to support clinical... ...for driving CMC regulatory submissions, managing Health Authority interactions... ...consistency, quality, and compliance with global regulatory...Full timeTemporary workRemote work- ...SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and... ...(CMC) will lead global CMC regulatory strategy and execution across Iambic's... ...high-quality CMC content for regulatory submissions, provide phase-appropriate regulatory guidance...Work at officeFlexible hours
$70k - $82k
...agendas, checklists, and sampling strategies aligned with risk and compliance priorities. Document findings... ...activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA... ...Therapeutics does not accept candidate submissions or referrals from recruiting...- ...Associate Regulatory Affairs ManagerCorDx a multi-national... ..., review, and submission of regulatory documents... ...regulatory projects, ensuring compliance with FDA, ISO 13485,... ...submission strategies.Participate in internal... ...mentorship to junior staff or specialists on assigned projects....Full time
$24.72 - $27.28 per hour
...of Quality Assurance and Contract Compliance, the Contract Compliance Specialist will support the Operations and... ...appropriate monitoring level and oversight strategy. Review and track subcontractor... ...the reports. Monitor report submission and follow up with staff as...Full timeContract workPart timeFor subcontractor$150k - $195k
...Summary: The Associate Director, Regulatory Project Manager (RPM) at... ...activities to ensure compliance with health authority requirements... ...This role supports regulatory submissions for investigational and... ...with the Regulatory Affairs Strategy leaders to create regulatory...Full timeTemporary workRemote workShift work$105.9k - $117k
POSITION SUMMARY:The Animal Program Compliance Specialist is a key member of the Institutional Animal... ..., research staff, and the IACUC on regulatory requirements and best practices.Reporting... ...members.Contribute to program strategy, develop institutional policies and SOPs...Full timeWork at officeFlexible hours- ...Responsibilities The Associate Director of Regulatory Affairs will provide regulatory... ...and implementing regulatory strategies for new product submissions, project management for regulatory... ...and maintaining documentation for compliance programs. Key Accountabilities...Work experience placementWork at officeRemote work
- ...vecnakraska.sk - Jobboard is seeking an Associate Director of Regulatory Affairs to provide regulatory support for medical... ...Diego site. This role involves developing regulatory strategies for new product submissions and handling existing registrations. The ideal candidate...Remote workFlexible hours
- ...OverviewUnder general supervision, the Contract & Compliance Analyst is responsible for analyzing... .... This role provides expertise in regulatory compliance, and vendor oversight, while... ...improvements, and risk mitigation strategies.Promote adherence to internal policies,...Contract workWork at officeLocal areaWork from home
$80.05k - $165k
...Cybersecurity and IT governance, risk, and compliance efforts, including the establishment... ..., and alignment with audit, risk, and regulatory expectations.Coordinate SOX IT Audit activities... ..., evidence collection, review, submission, issue tracking, status reporting to leadership...Full timeWork at office
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