Manager, Quality and Regulatory Affairs - Chester

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 ...

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

We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. · ...

We're Teva, a leading innovative biopharmaceutical company. · Here, you will be part of a high-performing, · inclusive culture that values fresh thinking and collaboration.You'll have the room to grow, · the flexibility to balance life with work, · and the opportunity to better h ...

The Recall Regulatory Specialist III will be responsible for leading OUS field action execution activities including managing Field Action Strategy Team meetings and coordinating document packages to notify regulatory agencies of field action activities. · ...

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

The Post Market · Regulatory Affairs Specialist is responsible for supporting post market regulatory affairs activities associated with complaint handling and MDR submissions.The specialist will oversee and directly support technical evaluations and investigation tasks required ...

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, · Develop and implement medical device regulatory strategies for West's administration and safety system product portfolio with an emphasis on gaining re ...

The Sr. Specialist, Regulatory Affairs is responsible for influencing department regulatory processes and procedures developing strategies authoring reviewing and supporting global registrations including Premarket Notifications China NMPA Registrations Technical Documentation fo ...

Job Summary · The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures. · ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · Contribute to the design and execution of global regulatory strategy for Ocugen's gene therapy programs. · Collabor ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · ...

The Associate Director of Regulatory Affairs - Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · Contribute to the design and execution of global regulatory strategy for Ocugen's gene therapy programs. · Collabor ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. This role is responsible for driving regulatory submissions and ensuring compliance with global regulatory requiremen ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · ...

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 ...

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 ...

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 ...

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 ...

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. · ...

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