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
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...
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 – 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...
Program Manager, Institute for Comparative and Regional Studies - Josef Korbel School
The Josef Korbel School seeks an energetic and experienced program manager to support the Institute for Comparative and Regional Studies (ICRS), its programs, as well as research-related activities school-wide. The program manager will serve as the administrative point-person for a diverse portfolio...
Clinical Science Program Manager
Job Title: Clinical Science Program Manager. The UCARE team is seeking applications for a Research Services Clinical Sciences Program Manager. Are you interested in supporting an internationally recognized program performing cutting edge clinical research in a highly stimulating academic environment...
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 Counsel Product and Regulatory Affairs
A company is looking for a Senior Counsel, Product and Regulatory Affairs (Liquidity). ...
Industrial Hygiene Project Manager
The IH Project Manager will report directly to the Landmark Operations Manager and will have project-specific lines of reporting to the Landmark’s Principals. The IH Project Manager will track to a Senior Project Manager position based on a series of professional growth and business metrics. The Ind...
Manager / Senior Manager, Compliance & Reporting Specialist
Work with KPMG's extensive network of specialists & enjoy access to our Ignition Centers, where deep industry knowledge merges with cutting-edge technologies to create innovative tax solutions. Global Compliance Management Services. Collaborate with and guide internal teams and clients through trans...
Managing Consultant, Environmental Regulatory Specialist (Senior Level)
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...