Senior Regulatory Affairs Specialist Jobs in Durham, NC

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...

Provide regulatory expertise by preparing submissions, ensuring compliance, and collaborating with teams to maintain quality guidelines, supporting product development efforts and compliance with glob...

Elevate compliance and risk management in FDA-regulated clinical research through expert leadership and quality oversight across clinical trials, ensuring effective protocols and inspection readiness...

Lead the charge in global regulatory strategies for innovative medical devices, driving project success from registration to compliance. Collaborate across teams to enhance healthcare technologies and...

Join a team that's dedicated to advancing regulatory strategies for innovative SaMD products. Collaborate cross-functionally to drive compliance, manage documentation, and ensure readiness for audits...

Drive regulatory excellence by managing submissions, guiding teams, and ensuring compliance. Utilize your expertise to support global projects and foster collaboration in a fast-paced environment focu...

Reimagine global compliance strategies as you guide regulatory submissions, assess product impacts, and collaborate across teams to ensure adherence to medical device regulations while enhancing quali...

Drive global regulatory labeling initiatives, ensuring compliance and quality of documentation across diverse markets. Lead strategic governance, influence policies, and collaborate cross-functionally...

Engage with a dynamic team to facilitate regulatory operations for novel therapeutics. Drive submissions to FDA/CVM while collaborating across multidisciplinary teams to set new regulatory standards i...

Innovate robust global regulatory frameworks to enhance compliance, drive quality initiatives, and support strategic goals across diverse teams while ensuring adherence to international standards and...

Unlock potential by leading regulatory CMC strategies for oncology products, coordinating submissions, and collaborating across teams to ensure compliance and successful product registration in a dyna...

Drive regulatory strategy by collaborating cross-functionally to influence promotional activities, ensuring compliance while optimizing risk management for impactful business decisions across a dedica...

Explore impactful quality assurance operations to ensure product integrity and compliance. Shape the future of manufacturing with your expertise in batch release processes and quality systems while su...

Shape the future of quality assurance in manufacturing by ensuring compliance with regulatory standards, conducting audits, mentoring teams, and driving continuous improvement initiatives in a complex...

Join a team dedicated to ensuring drug quality compliance by performing data integrity audits, assessing adherence to FDA standards, and providing actionable recommendations to enhance regulatory deci...

Take ownership of QA and compliance systems, driving continuous improvement and regulatory adherence through audits, product reviews, and cross-functional collaboration within the site to ensure inspe...

Collaborate with cross-functional teams to drive regulatory strategies and manage submissions for drug products. Provide expert guidance to ensure compliance and oversee regulatory activities througho...

Join our team to lead regulatory strategies across major programs, driving impactful submissions and fostering collaboration within a challenging and dynamic environment. Embrace the opportunity to in...

Elevate your career by leading Quality Risk Management and Data Integrity initiatives, ensuring compliance and operational excellence in a dynamic environment, while fostering a robust quality culture...

Manage and lead comprehensive validation activities in a GMP environment, ensuring compliance with FDA and EMA standards. Collaborate with cross-functional teams while mentoring junior staff and maint...

Optimize regulatory strategies and compliance globally by leading cross-functional projects, guiding teams, and liaising with health authorities throughout the drug development lifecycle to ensure suc...

Lead the charge in ensuring quality compliance during aseptic manufacturing operations. Collaborate with cross-functional teams to maintain high standards of regulatory adherence while supporting life...

Shape the future of regulatory strategy by leading cross-functional teams, driving innovative development strategies, and providing regulatory thought leadership to ensure compliance and accelerate pr...

Lead the charge in developing global regulatory strategies for clinical programs. Manage regulatory operations for product lifecycle while collaborating with cross-functional teams to ensure successfu...

Shape the future of medical devices by leading regulatory strategies, ensuring compliance across global markets, and mentoring a dedicated team. Empower innovation through effective communication with...