Senior Regulatory Affairs Specialist Jobs in North Wales, PA

Pioneer regulatory strategies for client access to investigational therapies. Leverage your expertise to inform business development, support dynamic client interactions, and refine methodologies that...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Contribute to critical labeling operations for GSS product portfolios by collaborating with cross-functional teams to ensure compliance and accuracy across all product labeling and documentation proce...

Drive labeling activities for GSS product portfolios, ensuring compliance and accuracy through collaboration with cross-functional teams. Manage documentation projects and improve processes within the...

Accelerate clinical trial success by optimizing monitoring strategies and processes for efficient, quality data management in alignment with regulatory standards and timelines...

Take ownership of EHS programs in research labs, ensuring safety compliance, managing risks, and leading inspections. Collaborate on facility designs and oversee contractor safety, creating a proactiv...

Join a team that's shaping the future of global regulatory strategy. Your expertise will drive compliance, oversee submissions, and lead a dynamic regulatory team in executing key strategies for produ...

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

Empower government sector success by identifying sales opportunities and leveraging legal tech expertise. Join a dynamic team to boost revenue through strategic outreach and relationship building whil...

Manage clinical studies to ensure compliance with regulations and human subject protection. Coordinate site monitoring and maintain quality standards while communicating effectively with site teams to...

Deliver end-to-end bioprocess solutions by leveraging deep expertise in biopharmaceutical workflows, guiding complex customer collaborations, and driving high-impact project leadership for long-term s...

Join a team that's advancing nuclear engineering through component qualification, structural analysis, and seismic qualification for new and existing facilities. Collaborate with multidisciplinary exp...

Transform global regulatory processes by leading approvals, strategizing submissions, and ensuring compliance for medical devices across diverse markets while collaborating with teams and serving as a...

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...

Tackle key stability programs for pharmaceutical products. Manage stability studies, ensure compliance with regulations, and collaborate across teams to support sample handling, protocol development...

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...

Empower innovation in regulatory CMC for biologics, leading strategies for antibody drug conjugates and bioconjugates, while ensuring compliance across all stages of product development and lifecycle...

Lead and execute global Regulatory CMC strategies for synthetic moieties in biologics, ensuring compliance through all phases of drug development. Collaborate cross-functionally to meet regulatory mil...

Join our team as a Senior Validation Specialist to provide LIMS and computer system validation expertise. Lead implementation efforts, support audits, and ensure compliance while collaborating with cr...

Champion operational excellence by providing technical support in engineering, maintenance, and utilities across diverse manufacturing environments, driving improvements and ensuring compliance with s...

Manage quality oversight for drug-device combination products, ensuring compliance with global regulations and quality systems from development to commercialization. Collaborate with cross-functional...

Join a team that's driving compliance excellence in supply chain operations. This role blends collaboration across Contracts, Legal, and Supply Chain, focusing on government contracting and ensuring r...

Advance supplier manufacturing efficiency by leading proactive oversight, collaborating with cross-functional teams, and enhancing critical supplier performance to meet company objectives and improve...

Lead quality assurance efforts in innovative medical device development. Act as a subject matter expert in compliance, design control, and risk management, ensuring product integrity throughout the so...

Join a team that's dedicated to enhancing clinical trial quality through leadership, mentorship, and oversight. Engage remotely with cross-functional teams, driving high standards for patient safety a...