Regulatory Affairs Specialists work to ensure that biotechnology or biopharmaceutical products meet all the quality attributes — safety, efficacy, potency and purity — required by customers and ...

In an ever-changing regulatory environment, the role of regulatory affairs personnel is essential to ensure compliance with legislation in all regions in which a company wishes to distribute its drug.

Regulatory affairs professionals may specialize in a particular geographic area (e.g., United States, European Union), in a product development phase (nonclinical, clinical, chemicals manufacturing ...

The Regulatory Affairs for Cell and Gene Therapy post-baccalaureate certificate program trains leaders for this growing discipline and prepares them to bring new therapeutics to market. Students learn ...

Overview Revitalize institutional workflows, elevate patient well-being, and adeptly maneuver through the intricacies of health systems. Purdue University’s online Regulatory Affairs Science for ...

Pharmaceutical Regulatory Affairs Market Trends Analysis Report 2025-2030: Demand for Faster Approval for Breakthrough Drugs and Devices, Growth in Personalized Medicine, Biosimilars, and Orphan ...

“His extensive background in regulatory affairs, combined with his leadership skills, will be a tremendous asset as we continue to navigate the complex regulatory landscape and bring our sustainable ...

OIRA — the Office of Information and Regulatory Affairs — is an obscure, but powerful federal office around the corner from the White House. President Trump has decided that it should get even ...

Dublin, Jan. 09, 2025 (GLOBE NEWSWIRE) -- The "Pharmaceutical Regulatory Affairs in China Training Course" conference has been added to ResearchAndMarkets.com's offering. This seminar will provide ...