... the coordination point for regulatory engagement and regulatory management of examination and ongoing ... coordination, development and review regulatory examinations draft responses (as required) ... -dots from all regulatory interactions, both exams and meetings ...
... and execution of global CMC regulatory strategies, ensure compliance with regulatory requirements, and represent Global CMC Regulatory Affairs in cross-functional and external ...
... lives.Were hiring a Principal Regulatory Affairs Specialist to join the EMEAP regulatory affairs team, which is growing to ...
... ventilatorio.Per il team Quality & Regulatory Affairs siamo alla ricerca di Un Una:Junior Regulatory Affairs SpecialistRiportando direttamente al QHSE RA ... - Cooperare con i team di Regulatory Affairs, Marketing e Sales delle altre ...
... needs.Your tasksParticipates as the Regulatory CMC Lead on CMC VST Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise and input to team ...
... doing: Under the guidance of Regulatory Affairs management: * Provide regulatory guidance to product development teams ... development of best practices for Regulatory Affairs processes. * Represents Regulatory Affairs on cross-functional project teams. * ...
... review if applicable. * Coordinates the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs and CMOs. * Contribute to KPIs ... etc.), or equivalent * Experience in Regulatory Affairs or any relevant experience in ...
... Johnson, we all belong. brbrThe Regulatory Affairs Manager is responsible for managing and leading the regulatory activities to obtain and maintain ... matter expert and leader for Regulatory Affairs, the individual will provide guidance ...
... deliver per the Global Regulatory Strategy (GRS), performing scenario planning, ... across markets. Contributes to Regulatory Asset Oversight function metrics and ... multiple assets. * Good knowledge of Regulatory Affairs responsibilities from pre-IND through ...
... instructed by the Director of Regulatory Operations. They are also encouraged to be an authority in the Regulatory Operations support processes and will assist junior members as necessary. They will ...