A company is looking for a Director, Regulatory Affairs.Key Responsibilities : Focus on clinical regulatory filings and providing strategic and operational leadership on project teamsContribute to IND / CTA and BLA submissions activities for products in developmentDevelop regulatory strategies for assigned programs and communicate with regulatory agenciesRequired Qualifications : 10 years of pharmaceutical industry experience, with at least 5 years in regulatory affairsM.
D., Ph.D., or Pharm. D. degree or equivalent work experienceStrong background in Regulatory Affairs with successful interactions with Regulatory AgenciesKnowledge of global regulations, particularly US FDA regulationsExperience in managing regulatory activities associated with drug development programs
Regulatory Affairs Director - Global Regulatory Leader
A company is looking for a Regulatory Affairs Director - Global Regulatory Leader in General Medicine/Cardiovascular. ...
Director/Principal Specialist, Regulatory Affairs
Director/Principal Specialist, Regulatory Affairs - Permanent - Denver, CO. Proclinical is seeking a Director/Principal Specialist, Regulatory Affairs for a rapidly growing and exciting medical technology company specializing in SaMD with AI/ML with their location in the Denver, CO area. The Directo...
Director Regulatory Affairs Advertising and Promotion
A company is looking for a Director/Senior Director, Regulatory Affairs Advertising and Promotion. Collaborate with cross-functional teams to incorporate regulatory considerations into materialsServe as primary liaison to FDA Office of Product and Drug Promotion (OPDP)Required Qualifications:Minimum...
Director, Regulatory Affairs – Texas/ERCOT
The Director, Regulatory Affairs will represent Invenergy before and manage relationships with state economic and environmental regulators, transmission system operators, and regional trade associations in Texas on behalf of Invenergy's existing assets as well as its pipeline of development projects...
Director Regulatory Affairs
Key Responsibilities:Focus on clinical regulatory filings and providing strategic and operational leadership on project teamsContribute to IND/CTA and BLA submissions activities for products in developmentDevelop regulatory strategies for assigned programs and communicate with regulatory agenciesReq...
Executive Director, Johnson Depression Center Open Rank- Associate Professor, Professor
In addition to the Executive Director, this includes the Adult Division Administrator, Medical Director, Deputy Director, Director of Community Education and Programs, Advancement and Events Program Manager, Project Manager, and a robust clinical administrative team. Executive Director, Johnson Depr...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist working independently, is responsible for fulfilling regulatory compliance requirements by applying an understanding of regulatory standards and regulations for medical devices, pharmaceuticals, or biologics. As a Senior Regulatory Affairs Specialist you play a p...
Senior Regulatory Affairs Manager
Key Responsibilities:Develop global regulatory strategies for Acute Care and Monitoring productsLead interactions with regulatory agencies and ensure compliance with regulationsProvide oversight of regulatory review of advertising and promotion materialsRequired Qualifications:Bachelor's Degree and ...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist responsibilities include, but are not limited to, the following:. Under the direction of the Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT’s laboratories are compliant w...
Project Manager
We have an immediate opportunity for a Project Manager in the El Paso County area. Ability to lead meetings reviewing the status of the project and project needs with leadership and team members. Project Manager, Utilities, Telecom, Construction, Excel, Planning, job tracking, permitting). This indi...