Director, Regulatory Affairs Jobs in Durham, NC

Join a team that's shaping the future of global regulatory affairs. You will lead compliance strategies for investigational products and marketing applications through effective submissions and collab...

Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...

Join a team that's dedicated to ensuring compliance in promotional activities for CNS treatments while navigating regulatory pathways in a fast-paced environment. Help shape communications, drive stra...

Lead the charge in managing large, complex regulatory projects, ensuring quality deliverables while overseeing cross-functional teams, driving strategic consultancy, and innovating solutions for compl...

Deliver strategic regulatory leadership for global development programs, overseeing regulatory strategy and execution from late-stage clinical phases to marketing authorization while ensuring complian...

Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

Champion CMC regulatory submissions by authoring high-quality dossiers for radiopharmaceuticals and biopharmaceuticals, ensuring compliance and collaboration across teams throughout the product lifecy...

Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...

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...

Build your influence by leading a skilled team in Regulatory Affairs, driving strategic initiatives, enhancing performance, and managing projects that impact regional and global objectives while ensur...

Lead the development of global regulatory strategies and ensure compliance throughout the product lifecycle, from pre-approval to post-approval, as a strategic partner and advisor to cross-functional...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Unlock potential by shaping global regulatory strategies that enable successful product launches. Collaborate across functions to ensure compliance and lead innovative submission processes throughout...

Shape regulatory strategies for innovative medical devices, engage with health authorities, and drive project success. Collaborate with cross-functional teams to influence industry standards and ensur...

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

Champion quality and compliance by leading the Quality Control & Regulatory Affairs team, ensuring adherence to industry standards and driving operational excellence for product lines and team perform...

Empower global labeling excellence by managing regulatory compliance, overseeing document governance, and collaborating with cross-functional teams to ensure safe and effective use of innovative medic...

Engage as a strategic regulatory expert, guiding clients in navigating complex pathways for patient access to investigational therapies while driving market growth and operational excellence through c...

Join a dynamic team as you drive regulatory strategies and ensure compliance in post-approval activities for CMC processes. Collaborate cross-functionally, influencing clinical outcomes and advancing...

Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...

Lead the development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...

Drive regulatory strategies and oversee compliance for investigational therapies. Work cross-functionally to ensure timely regulatory filings and maintain vendor relationships, contributing to clinica...

Collaborate with cross-functional teams to optimize ICSR management, enhance productivity, and mentor leaders, ensuring efficient resource allocation and driving excellence in pharmacovigilance projec...

Take ownership of regulatory affairs operations, leading teams to enhance processes within clinical trials while ensuring compliance with regulations and fostering collaboration across departments...