Senior Regulatory Affairs Specialist Jobs

Champion impactful pharmacy licensing initiatives, enhancing compliance and operational efficiency while leading cross-functional teams. Drive projects from concept to execution to support organizatio...

Manage the governance of the enterprise-wide specimen collection kit program. Oversee quality assurance initiatives, ensure regulatory compliance, and implement a robust Quality Management System to e...

Join a team that's dedicated to ensuring vaccine quality and safety by overseeing compliance and operational excellence in aseptic manufacturing processes. Collaborate with experts and CMOs to drive c...

Join a team that's committed to elevating quality assurance for medical devices. Collaborate with cross-functional teams to implement rigorous verification, validation, and risk management strategies...

Empower the Regulatory Affairs team by driving compliance and strategy across global projects. Lead regulatory submissions, monitor changes, and collaborate with stakeholders to ensure successful prod...

Shape the future of regulatory affairs by leading original ANDA submissions for complex generics, collaborating with cross-functional teams to ensure compliance, accuracy, and timely submission of reg...

Support the Quality Management System by reviewing and approving key documentation, ensuring compliance with regulations. Champion best practices in discrepancy reporting and CAPA processes while coll...

Drive regulatory excellence in product innovation, ensuring compliance and safety while empowering creativity and strategy across teams in a dynamic, collaborative environment. Be the key connector be...

Lead global strategy for Notified Body engagement, ensuring compliance, managing audits, and driving certification readiness across various jurisdictions. Guide integration assessments, enhance proces...

Drive excellence in Government Property management, ensuring compliance and inventory accuracy. Collaborate across teams to enhance processes while mentoring staff, maintaining audit readiness, and su...

Shape the future of regulatory affairs by providing strategic leadership in biologics for rare diseases. Oversee late-stage clinical development to ensure compliance, efficient submissions, and succes...

Transform regulatory strategies to enhance patient access to diagnostics, managing complex submissions and fostering relationships among stakeholders to navigate evolving regulations and improve outco...

Lead the charge in developing innovative regulatory strategies and submissions for diabetes care products. Utilize your expertise to navigate global regulatory landscapes and drive compliance across p...

Elevate quality assurance standards by implementing improvements, conducting audits, and ensuring GMP compliance. Collaborate across teams to enhance processes and lead initiatives that foster a cultu...

Join a team that's dedicated to enhancing quality in aerospace manufacturing through proactive product surveillance and audits. This floor-embedded role aims to minimize scrap, prevent nonconformances...

Advance quality excellence in cell therapy operations by ensuring cGMP compliance, overseeing manufacturing activities, and collaborating across teams to resolve issues and drive improvements while ma...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

Tackle regulatory challenges by overseeing compliance of promotional materials, advising on advertising strategies, and managing interactions with the FDA. Drive regulatory initiatives, ensuring align...

Serve as a key resource in regulatory affairs, managing compliance for advertising, promotional materials, and product labeling. Lead interactions with regulatory authorities while ensuring alignment...

Optimize regulatory compliance processes, ensuring adherence to FDA and ISO standards. Collaborate with internal and external stakeholders while managing product-specific submissions and risk assessme...

Lead and ensure compliance with state and federal regulations for products. Collaborate across facilities to mitigate risks, conduct audits, manage inspections, and oversee licensing while developing...

Take ownership of regulatory strategies and submissions for cutting-edge companion diagnostics. Lead a team while interfacing with cross-functional groups and regulatory authorities to navigate the ap...

Shape quality management for clinical trials, leading risk assessments and collaborations to ensure compliance and excellence within a dynamic, science-driven environment...

Unlock quality excellence in global clinical trials by leading risk-based management strategies. Collaborate across teams to ensure compliance and enhance processes, making a meaningful impact in pati...

Join us to lead risk-based quality management in clinical trials, driving comprehensive quality assessments and ensuring inspection readiness. Collaborate with teams to uphold high standards in pharma...