Regulatory Affairs Specialist Jobs in West Chester, PA

Elevate project success by managing permit tracking and regulatory compliance, ensuring adherence to local, state, and federal requirements while supporting incentive-related activities for optimal be...

Champion complex regulatory strategies for combination products, leading cross-functional teams to navigate global requirements and ensure successful development, registration, and lifecycle managemen...

Transform regulatory strategies by leading complex combination product initiatives. Collaborate with cross-functional teams to ensure compliance and successful lifecycle management of innovative medic...

Shape the future of combination product regulatory strategies by leading complex programs and providing expert guidance on evolving global requirements. Collaborate across teams to ensure successful d...

Partner with us to innovate and transform Quality & Regulatory operations through technology and data analytics. Drive automation, improve efficiency, and foster effective digital solutions that enhan...

Unlock potential by leading regulatory compliance for IVD products, ensuring adherence to global standards. Collaborate with cross-functional teams to assess risks, manage adverse events, and drive co...

Champion the U.S. Biologics Regulatory CMC team by providing strategic leadership, ensuring timely regulatory submissions, and fostering collaboration among global stakeholders to drive innovative bio...

Lead the charge in developing and executing regulatory CMC strategies for small molecules or biologics, ensuring compliance with global regulations while managing a team to deliver key milestones thro...

Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...

Drive the substantiation of health claims for dietary supplements by reviewing scientific evidence and collaborating with cross-functional teams to ensure compliance with regulatory standards and enha...

Optimize clinical research agreements by managing negotiations, execution, and compliance. Collaborate with cross-functional teams to enhance efficiency and quality in clinical trial operations, ensur...

Drive global regulatory strategies for obesity and cardiometabolic disorders, ensuring alignment across teams and leading interactions with health authorities. Leverage scientific expertise to navigat...

Drive quality assurance initiatives by designing and implementing risk-based surveillance programs, ensuring contractor compliance, and enhancing processes to support diverse products and services for...

Join us to implement a risk-based quality assurance program, ensuring contractor compliance and enhancing processes. Collaborate with multi-functional teams to support U.S. Government acquisitions in...

Champion patient safety and product excellence as a Sr. Medical Affairs Specialist. Collaborate with cross-functional teams to provide clinical expertise, develop medical communications, and support p...

Elevate clinical research standards by ensuring compliance and data integrity through effective site management and monitoring. Collaborate with teams to drive successful trial execution and achieve e...

Shape the future of regulatory affairs by leading CMC strategies for innovative products, ensuring compliance and quality in submissions, and collaborating with global teams to drive successful market...

Drive enterprise Quality and Regulatory governance for U.S. operations, ensuring compliance with FDA regulations and overseeing manufacturing quality in the therapeutic radiopharmaceutical sector whil...

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...

Unlock potential by guiding global regulatory strategies for innovative AI/ML healthcare solutions. Collaborate cross-functionally to navigate complex regulations while balancing innovation and patien...

Elevate your career by managing clinical sites and ensuring study quality, patient safety, and regulatory compliance. Collaborate with site teams to support enrollment and deliver impactful clinical r...

Engage in quality operations for externally manufactured pharmaceutical products, managing relationships with CMOs and cross-functional teams. Ensure compliance, oversee batch reviews, and drive conti...

Champion compliance excellence by leading advertising review processes, enhancing operational workflows, and implementing innovative solutions to support rapid growth while ensuring adherence to regul...

Elevate your career by leading CMC Regulatory strategy and execution. Drive submissions, build a high-performing team, and engage with global health authorities to ensure compliance and success in dru...

Join a team that's shaping the future of regulatory science by supporting strategic engagements across pharmaceuticals and medical devices. Collaborate with experts to navigate complex challenges and...