Attorney Government and Regulatory Affairs - Cherry Hill, NJ

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 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. · ...

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 ...

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

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. · ...

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 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. · ...

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 ...

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. · ...

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

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. · ...

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

IntePros is currently looking for a Regulatory Affairs Manager to join one of our growing Medical Device clients in Audubon PA.The Regulatory Affairs Manager is responsible for preparing filing and gaining approval of 510 k IDE and PMA submissions to the U.S. Food and Drug Admini ...

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 ...