Vice President, Accreditation and Regulatory Affairs - Philadelphia, PA

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 ...

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. · ...

· 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 ...

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 ...

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. · ...

About the Position · This role can be remote or based out of our Philadelphia, PA headquarters. · Reporting to the Chief Medical Officer, the Vice President of Regulatory Affairs is responsible for driving success and will lead the global regulatory strategy and execution for an ...

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 ...

+Job summary · Exciting Leadership Potential | RETAINED SEARCH · +ResponsibilitiesReporting to the Chief Scientific Officer, you will provide leadership in regulatory activities for programs in development... · ...

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 Philadelphia Gas Works is looking for a challenge in their Customer Complaints & Regulatory Affairs department. · Liaison with constituency services for internal departments within Customer Affairs and external agencies related to State, Federal and Local government. · Invest ...

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. · ...

· Overview · Philadelphia Gas Works  · Looking for a challenge and ready to light up your career?  · The Philadelphia Gas Works (PGW) is the largest municipally-owned gas utility in the nation, supplying gas service in the City of Philadelphia to over 500,000 customers.  From ...

The Philadelphia Gas Works (PGW) is the largest municipally-owned gas utility in the nation. Looking for a challenge and ready to light up your career? Become part of the PGW Team as Supervisor - Customer Complaints & Regulatory Affairs. · Dispute Resolution AdministrationLiaison ...

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 ...

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. ...

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. · ...