Director, Clinical Regulatory Affairs - Wilmington

The job involves regulatory review of new supplier & part qualifications. It includes submissions to EU and FDA. The candidate should be able to negotiate and build relationships with FDA, EU Notified Bodies, Health Canada etc. · The experience in preparing and submitting regulat ...

The Assistant Director of Research Regulatory Affairs works directly with the Director of Research Security in the Research Office to analyze and resolve research-related issues. · Makes recommendations on University research activities. · Reviews and negotiates agreements. · ...

The contractor will work within a team to execute regulatory strategies and gain approval for global post approval changes. · Knowledge of global CMC guidelines regarding post approval changes. · Execution of detailed, global regulatory strategies for submission and approval of p ...

Cytokinetics is seeking a highly motivated Intern to join its Regulatory Affairs group. The internship will provide hands-on insights and working experience of several regulatory operations and affairs functions. · ...

A growing medical device organization seeks a Manager, Regulatory Affairs to lead U.S. regulatory submissions for Class II and Class III products. · Bachelor's degree in engineering, life sciences, or related technical field (Master's preferred) · 8+ years in the medical device i ...

IntePros is currently looking for a Regulatory Affairs Associate to join one of our growing Medical Device clients in Audubon, PA. · ...

This position will have an emphasis on Chemistry, Manufacturing, and Controls (CMC) regulatory strategies and document preparation but will also have exposure to strategic and tactical regulatory affairs activities supporting the clinical and nonclinical projects within Regulator ...

The Director of Regulatory Affairs will lead assigned projects · and all regulatory affairs activities by providing expertise · to Immunocore’s development programs.This includes developing · regulatory scientific and tactical strategies, · maintaining INDs/BLAs/MMAs, · oversee ...

Cytokinetics is seeking a highly motivated Intern to join the Regulatory Affairs group. · ...

We are seeking a highly motivated Intern to join our Regulatory Affairs group at Cytokinetics. · Cytokinetics is building on its over 25 years of pioneering scientific innovations in muscle biology and advancing a pipeline of potential new medicines for patients suffering from di ...

The Regulatory Affairs Manager will be responsible for managing and conducting US regional regulatory activities as directed by management. This includes leading regulatory activities for assigned projects in line with US regulatory requirements. · BA/B.S in a scientific, healthc ...

We're on a mission to make good health more affordable and accessible to help millions around the world enjoy healthier lives. · ...

You will lead regulatory process improvements and support regulatory activities across the United States. · You will work closely with cross-functional teams, external partners, and senior leaders to simplify processes, reduce cycle times, and improve quality. · ...

A growing medical device organization is seeking a Manager, Regulatory Affairs to lead U.S. regulatory submissions for Class II and Class III products. · ...

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. · ...

We are seeking a highly motivated and experienced Regulatory Affairs Director to support the development and implementation of global regulatory strategy for our next-generation precision oncology company focused on the development of Plixorafenib. · ...

+At Globus Medical we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders Our team is inspired by the needs of these patients and the surgeons who treat them We embrace a culture of exceptional response b ...

Supports necessary regulatory activities required for product market entry. · ...

We are hiring a Regulatory Affairs Contractor for one of our clients. The contractor will be responsible for regulatory review of products, writing 510k sections, being regulatory liaison between different business verticals. · ...

The Director of Regulatory Affairs will oversee assigned projects and all regulatory activities by providing expertise to Immunocore's development programs. · ...

The Abramson Cancer Center (ACC) of the University of Pennsylvania seeks a Regulatory Affairs Specialist-CC to coordinate Phase I-V clinical trials. · Prepare and process all regulatory documentation through IRB, CTSRMC, FDA. · Organize and maintain regulatory affairs documentati ...