CMC Regulatory Affairs - Cherry Hill

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 ...

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. · ...

We are one of the fastest growing IT Consulting company across the USA and we are hiring Regulatory Affairs Specialist for one of our clients. · This position is responsible for assisting with the preparation, coordination and monitoring of routine US regulatory submissions (e.g. ...

Support regulatory activities including preparation and submission of Annual Reports and supplements to FDA for approval. · Reviews and approves labeling for revisions to current products. · Drafts revised labeling (Package Inserts) for marketed products based on FDA requirements ...

Malamut Law is seeking a skilled and motivated Labor & Employment Attorney to join our growing team. · Represent employers in labor and employment matters. · Handle traditional labor law matters including collective bargaining negotiations. · ...

Malamut Law is seeking a skilled Labor & Employment Attorney to join our growing team. · Represent employers in labor and employment matters. · ...

Malamut Law es una firma legal centrada en los clientes con una dedicación a la justicia laboral y al servicio del cliente. · Representar a los empleadores en asuntos laborales y de empleo. · Hacer consejería regular para diversas cuestiones relacionadas con leyes laborales y de ...

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 ...

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. · ...

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

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 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 ...

The Regulatory Affairs Specialist is responsible for preparing, reviewing, and maintaining regulatory submissions and documentation required for US FDA approvals of high-risk medical devices. · ...

This role will lead regulatory activities for SERB's products developing and implementing preparation of submissions relevant to assigned products and/or projects to FDA. · ...

The Abramson Cancer Center (ACC) of the University of Pennsylvania seeks a full-time Regulatory Affairs Specialist-CC to participate in the coordination of Phase I-V clinical trials. · The successful candidate will prepare and process all regulatory documentation through the IRB, ...

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. · ...

Job summary: Regulatory Affairs Specialist to join one of our growing Medical Device clients in Audubon, PA. · ...

This role involves leading regulatory activities for SERB's products and collaborating with Global Regulatory Affairs teams. · ...

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. · ...