Medical Director, Clinical Regulatory Affairs - Dallas

+The Regulatory Affairs Coordinator will act as liaison between NEXT Oncology (an Avacare business), the Institutional Review Board, and various Pharmaceutical and Biotech companies (Sponsors) to open clinical trials at NEXT Oncology. · +Submit new studies to the Institutional Re ...

The Regulatory Affairs Manager is responsible for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products. · ...

Job summary · A Regulatory Affairs role is available with responsibilities including NDC registration and Cosmetic Product Listing submission. · Key Responsibilities:NDC registration · Cosmetic Product Listing submission · ...

The ideal candidate will have a general understanding of ratemaking and strong accounting knowledge. · Directs the advocacy of the Company's positions on Ratemaking and other regulatory issues before various federal, state and; local regulatory agencies. · ...

The ideal candidate will have a general understanding of ratemaking and strong accounting knowledge. · ...

+Job summary · Mgr Rates&Regulatory Affairs directs the advocacy of the Company's positions on Ratemaking and other regulatory issues before various federal, state and local regulatory agencies. · +Directs the advocacy of the Company's positions on Ratemaking and other regulatory ...

This position involves conducting clinical research monitoring auditing quality assurance reviews internal quality reviews and other administrative and regulatory reporting tasks with minimal supervision.Applicationbased knowledge of federal regulations ICH-GCP guidelines HIPAA g ...

+We are building a world-class team to advance transformative therapies from early development through global registration. · +Serve as regulatory lead for interactions with FDA (CBER), EMA, and other global health authorities · Lead and participate in FDA and EMA meetings (pre- ...

Secretome Therapeutics is seeking a Regulatory Affairs professional to lead and execute global regulatory strategy across our pipeline of cell and stem-cell–based therapies. · ...

+Job summary · Oscar is hiring a Medical Director to join their Clinical Affairs team. · ++Lead and grow the Clinical Policy & Regulatory Affairs team. · +Develop and maintain BIPs, SOPs, and other clinical policy documents aligned with QMS. · +Serve as a regulatory compliance ex ...

You enjoy shaping the future of product innovation as a core leader driving value for customers guiding successful launches and exceeding expectations. · Develops a product strategy and product vision that delivers value to customers.Manages discovery efforts and market research ...

You will drive value for customers by delivering high-quality products that resonate with clients. As a Product Manager in Deposits 2.0, you develop profitable products that provide customer value. · ...

The Regulatory Affairs Coordinator will act as liaison between NEXT Oncology (an Avacare business), the Institutional Review Board, and various Pharmaceutical and Biotech companies (Sponsors) to open clinical trials at NEXT Oncology. · ...

The Regulatory Affairs Coordinator will act as liaison between NEXT Oncology and the Institutional Review Board to open clinical trials. · ...

This position involves conducting clinical research monitoring auditing quality assurance reviews internal quality reviews and other administrative regulatory reporting tasks with minimal supervision. · ...

The overall goal of the Regulatory Affairs Manager is to ensure regulatory clearance for all FX products in all markets and compliance with all applicable regulations. · Bachelor's degree required. · 5+ years' experience in progressive positions with responsibilities for regulato ...

The overall goal of the Regulatory Affairs Manager is to ensure regulatory clearance for all FX products in all markets and compliance with all applicable regulations. · Bachelor's degree required. · 5+ years' experience in progressive positions with responsibilities for regulato ...

Join our client's Regulatory Affairs team to support the transition to the EU's In Vitro Diagnostic Regulation (IVDR). This role plays a critical part in ensuring regulatory compliance by revising technical documentation, updating labeling, and coordinating regional notifications ...

We are seeking a Regulatory Affairs Specialist II to support the European Union In Vitro Diagnostic Regulation (IVDR) transition efforts impacting Bio-Rad products currently CE-marked under the IVD Directive.This role will focus on technical file remediation labeling conversions ...

We are seeking a Regulatory Affairs Specialist II to support the European Union In Vitro Diagnostic Regulation (IVDR) transition efforts impacting Bio-Rad products currently CE-marked under the IVD Directive. · Bachelor's degree in Biochemistry, Biology, Medical Technology , or a ...