Regulatory Affairs Manager Jobs in Durham, NC

Reimagine Regulatory Affairs by leading complex outsourcing programs and driving client success. Utilize deep expertise in strategy and operations to manage projects, mentor teams, and deliver tailore...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Lead the charge in ensuring regulatory compliance globally for Expanded Access Programs, enhancing patient access to innovative therapies through collaboration across diverse teams while maintaining q...

Elevate product registration processes by leading global regulatory strategies, preparing detailed dossiers, and ensuring compliance with labeling requirements across diverse markets to facilitate pro...

Lead the charge in regulatory strategy for clinical studies, providing expert guidance on complex global compliance. Drive communication with health authorities and ensure timely documentation while c...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

Transform regional regulatory engagement by leading strategy, fostering relationships, and advocating for efficient electric transmission policies. Collaborate across departments to align regulatory g...

Champion regulatory excellence by guiding cross-functional teams in FDA advertising compliance while mitigating risks and enhancing strategic communications to support business goals...

Shape the future of compliance management by leading strategic quality initiatives and ensuring adherence to global regulations in a dynamic manufacturing environment, while fostering team collaborati...

Drive the Quality Risk Management program, ensuring compliance with regulations and site policies, while leading initiatives for continuous improvement and effective training in risk management practi...

Take ownership of U.S. regulatory submissions, ensuring accuracy and compliance with FDA requirements. Collaborate cross-functionally to coordinate IND, NDA, and BLA filings, executing processes withi...

Tackle molecular characterization studies and safety reports to support regulatory submissions for GM crops. Collaborate with cross-functional teams and provide expertise in molecular biology, ensurin...

Accelerate progress at the forefront of pharmaceutical development by leading regulatory strategies. Collaborate cross-functionally to ensure timely submissions and compliance with FDA standards, driv...

Join a dynamic team managing 20-30 pharmaceutical clients, driving client satisfaction and revenue growth while leveraging industry-leading data solutions to create impactful business relationships an...

Transform the Regulatory Intelligence function, ensuring seamless regulatory compliance, strategic insights, and operational excellence across diverse programs and markets. Guide stakeholders by devel...

Join a team that's dedicated to delivering high-quality projects while managing client relationships, financial performance, and operational excellence in a fast-paced environment requiring strong lea...

Pioneer regulatory strategies and lead scientific project initiatives, ensuring compliance and alignment between regulatory, scientific, and business teams. Drive complex projects from inception to co...

Lead the establishment of a robust Product Quality function, enhancing governance and processes for evaluating lending products to ensure compliance, reliability, and accuracy across the financial ser...

Champion quality compliance across manufacturing operations, leading the review and disposition of materials and batches. Collaborate cross-functionally, driving a quality mindset while ensuring adher...

Contribute to enterprise leadership in product safety risk management, ensuring compliance and aligned processes throughout the medical imaging software product lifecycle, and leading a team of safety...

Join us to ensure quality compliance and drive continuous improvement by overseeing global quality investigations, facilitating stakeholder interactions, and implementing corrective actions based on r...

Champion regulatory compliance by supporting quality processes and product lifecycle management in the medical device sector, ensuring adherence to standards during design, development, and commercial...

Champion regulatory excellence by leading global strategies for product approvals, collaborating with cross-functional teams and external experts to ensure compliance and drive successful commercializ...

Help us drive Quality Operations excellence by leading a high-performing team within a multi-client GMP environment, ensuring compliance and inspection readiness while fostering operational growth and...

Join us to support analytical method validation and technology transfer, ensuring compliance and product quality. Collaborate across teams to drive regulatory success for small molecules and ASO produ...