Senior Regulatory Affairs Specialist Jobs in Raleigh, 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...

Shape the future of drug development by leading nonclinical regulatory strategies and engagements. Collaborate with multidisciplinary teams and clients to drive clinical progress, ensuring compliance...

Elevate your expertise by joining a dynamic team that drives nonclinical regulatory strategies for drug, biologic, and vaccine development, ensuring advancement from discovery to clinical approval whi...

Lead the charge in developing strategic nonclinical regulatory pathways that accelerate medical product advancements, partner with multidisciplinary teams, and navigate complex regulatory landscapes t...

Join a team that shapes global regulatory strategy in a fast-paced environment. You will lead comprehensive regulatory plans, ensuring alignment and execution from development to post-marketing, impac...

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...

Champion regulatory strategies and submissions for global medical products, ensuring compliance across major markets while leading cross-functional teams and driving process improvements in a collabor...

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...

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...

Shape the future of regulatory strategy by leading projects that ensure compliance and market access. Drive collaboration across teams while managing processes for development and post-approval phases...

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 a team that's shaping regulatory strategies for pharmaceutical products. Lead CMC regulatory activities, collaborate with cross-functional teams, and provide guidance. Actively mentor junior staf...

Join a dynamic team driving regulatory CMC strategies to advance innovative treatments. Collaborate with cross-functional teams while mentoring junior staff and managing complex regulatory submissions...

Engage with cross-functional teams to ensure regulatory compliance for Expanded Access Programs. Drive essential strategies and submissions while staying aligned with global legislation, impacting pat...

Lead the charge in transforming global regulatory strategies into successful outcomes. Oversee regulatory activities and empower teams to ensure quality compliance, timely delivery, and robust cross-f...

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...

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...

Join a dynamic team as a Senior Specialist, Quality Engineer, providing critical oversight in GMP operations at a leading biopharmaceutical facility, ensuring compliance, audit readiness, and quality...

Join a team that manages site activation processes, ensuring compliance with regulations and SOPs. Collaborate with project teams to maintain timelines, oversee deliverables, and provide expert guidan...

Unlock potential by leading complex investigations and regulatory inspections in biologics manufacturing. Collaborate across teams to ensure compliance, improve processes, and prepare for audits while...

Provide comprehensive Regulatory Affairs support to ensure full compliance with U.S. FDA medical device regulations and international standards, facilitating product submissions and ongoing industry c...

Deliver impactful CMC regulatory support for IND/CTA development and maintenance, ensuring compliance and completeness across submissions while leading cross-functional collaboration and strategically...

Drive regulatory compliance for a diverse portfolio of connected products. Collaborate with engineering teams to ensure adherence to global standards, leading testing efforts and strategy in a dynamic...

Drive compliance excellence by overseeing regulatory adherence for complex benefit products. Collaborate with cross-functional teams, conduct risk assessments for innovations, and support escalations...