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Minimum of 10-12 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Brightline Defense is seeking an entrepreneurial Policy Director with the ability to develop and contribute to the development of legal / regulatory affairs strategy in support of ambitious policy objectives.
$125,000 - $140,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Collaborate with cross-functional teams across Medical and scientific affairs, Data Science & Engineering, compliance, privacy, regulatory, IT, among others, to help shape and evolve the medical omnichannel solution roadmap and enhance evidence generation & dissemination strategies.
$113,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Support Danaher Diagnostic Operating Company's Medical and Scientific Affairs and Government Affairs organizations on their strategy so that it maximizes patient impact at scale. Identify new research opportunities beyond the OpCo or Platform core R&D efforts and support strategic IP management, as well as guidance around FDA and international regulatory matters, partnering with Platform and OpCo legal counsel.
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The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead. Develops meaningful and collaborative relationships with cross-functional teams and leaders across CMC RA and PDM. Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy. Contribute to the content strategy and define the storyline for regulatory applications and dossiers through product development and to marketing authorization.
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You will work across divisions including stakeholders across Global Marketing, Commercial Leadership, Research & Development, Medical & Scientific Affairs, Operations, Quality Assurance & Regulatory Affairs and Finance.
$118,000 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Cross-Functional Collaboration: Work collaboratively across departments to integrate brand strategy, fostering partnerships with Sales, Medical Affairs, Market Access, Regulatory, and Legal teams to achieve aligned objectives.
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Participate as Global Product Strategy Lead in cross-functional teams, including but not limited to, contract research organizations (CROs), functional working groups, global regulatory team, submission team, product development team, to ensure compliance with regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Director of RA oversees the following functions: Regulatory Strategy, Regulatory Operations, and Regulatory Intelligence. Lead and mentor a team of regulatory affairs professionals, fostering their growth and development.
$160,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, (the globe minus US, EU, Canada.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Role: Sr Spec, Regulatory Affairs. Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The Director, Regulatory Affairs is responsible for overseeing the company’s compliance and regulatory strategy. Minimum of five (5) years’ direct regulatory affairs and quality assurance experience in the biotech/pharmaceutical industry.
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Supports Program Lead MD (and/or Sr. MD) and frequently lead interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal collaborators (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards.
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