Sr Associate 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 ...

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 ...

· Job Title: Regulatory Affairs Associate · JOB PRUPOSE · Responsible for ongoing support of regulatory activities, including preparation and submission of Annual Reports, Annual Product Reviews, foreign registrations, change controls and labeling review and proofreading.  Addit ...

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. · ...

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 ...

· Location: Malamut Law/Cherry Hill NJ · Position Type: Full-Time · Experience Level: All experience levels welcome to apply.  · About Malamut Law · Malamut Law is a client-focused law firm driven by Integrity, Compassion, and Commitment. With extensive experience, we deliver po ...

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 ...

University Overview · The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World ...

· Come and Save Lives with Us · SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies. · For over 30 years we have consistently provided emergency medicine ...

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 is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. · ...

University Overview · The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World ...

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. · ...

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. · ...

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 ...

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Capital Health es la líder regional en proporcionar atención médica progresiva con inversiones significativas en nuestros destacados profesionales de la salud, enfermeras y personal excepcionales. · ...