Otsuka Pharmaceutical Companies (U.S.)
Santa Fe, NM, USA
The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the impact of regulatory changes to the pharmaceutical environment. Job Description Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated regulations and guidance that may impact pharmaceutical practices, procedures and controlled documents. Lead weekly regulatory intelligence team meetings to include review and discussion of ad hoc query requests, regulatory background package requests, health authority guidance, Federal Register notices, public commenting opportunities, and newsletter content. Manage development and distribution of weekly regulatory intelligence newsletters and regulatory watch notifications. Ensure regulatory intelligence specialists have continued access to regulatory, clinical trial, and public domain...


