Senior Regulatory Affairs Specialist Jobs in Durham, NC

Lead the charge in Site Activation activities, ensuring compliance with regulations and project timelines, while serving as the single point of contact for investigative sites and project teams to opt...

Lead regulatory compliance programs ensuring inspection readiness and proactive risk management across cross-functional teams. Monitor compliance health, manage data quality, and drive improvements al...

Lead global regulatory strategies for oncology programs, ensuring compliance and effectively interacting with regulatory agencies for product approvals in late-stage development...

Join a team that's advancing regulatory strategies for drug substance manufacturing. Lead the charge in selecting and justifying Regulatory Starting Materials, ensuring compliance with global guidelin...

Unlock potential by driving regulatory submissions and managing documentation. Collaborate with global teams to align on strategies, ensuring compliance and effective communication while fostering a c...

Engage with regulatory authorities as you oversee the process of acquiring and maintaining essential pesticide registrations. Collaborate with cross-functional teams to ensure compliance and drive inn...

Manage the governance of the enterprise-wide specimen collection kit program. Oversee quality assurance initiatives, ensure regulatory compliance, and implement a robust Quality Management System to e...

Join a team that's dedicated to ensuring vaccine quality and safety by overseeing compliance and operational excellence in aseptic manufacturing processes. Collaborate with experts and CMOs to drive c...

Join a team that's committed to elevating quality assurance for medical devices. Collaborate with cross-functional teams to implement rigorous verification, validation, and risk management strategies...

Lead global strategy for Notified Body engagement, ensuring compliance, managing audits, and driving certification readiness across various jurisdictions. Guide integration assessments, enhance proces...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

Elevate the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...

Accelerate regulatory strategy development for oncology products, leading global initiatives to secure IND/CTA approvals and marketing applications. Collaborate with cross-functional teams to navigate...

Champion regulatory excellence by leading postmarket strategies for product compliance, driving collaboration across teams to ensure timely submissions and navigate complex regulatory landscapes for c...

Contribute to regulatory excellence by coordinating U.S. submissions, ensuring compliance with FDA standards, and maintaining vital documentation for the Obesity Therapeutic Area, while collaborating...

Unlock your potential by overseeing site management and monitoring for clinical trials, ensuring compliance with regulations and enhancing site relationships to drive quality and timely delivery of cl...

Lead end-to-end GCP audits globally, ensuring compliance and driving improvements in clinical studies. Collaborate with stakeholders to interpret regulations and support regulatory inspections in a dy...

Innovate the future of regulatory labeling by driving strategies across global teams, ensuring compliance and quality at all stages of product development while collaborating with key stakeholders to...

Lead high-profile statistical projects, ensuring rigorous evidence generation by collaborating with multi-functional teams to design studies and analyze data effectively...

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

Champion the validation of cutting-edge lab instrumentation while collaborating with diverse teams to ensure customer readiness and operational excellence. Your expertise will drive quality and compli...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Transform regulatory writing by leading complex submissions, mentoring teams, and ensuring compliance. Drive innovation and improve processes while collaborating across teams to enhance product succes...

Drive impactful medical communication strategies by crafting precise scientific content and collaborating with cross-functional teams to meet diverse client needs within a dynamic healthcare landscape...

Drive validation excellence by leading compliance initiatives and continuous improvements in GxP practices. This senior role influences operational efficiency, guides team growth, and ensures adherenc...