5 results for Regulatory Affairs Associate Jobs in Mountain View, CA, US

SUMMARY:Fortvita Biologics is seeking a Senior Manager/ Associate Director of Regulatory Affairs US Lead, supporting the department head for developing and implementing global strategies to secure and maintain market approval for product(s) globally (US, EMA, Japan, Australia, Canada). The incumbent...

Manage the commercial regulatory strategy for high-volume brands, oversee and review promotional materials, chair Promotional Review Committee meetings, and provide regulatory guidance on marketing concepts and campaigns. Ensure compliance with FDA regulations while representing commercial activitie...

Responsible for managing regulatory activities for liver drugs, leading regulatory strategy and team meetings, preparing regulatory documentation, ensuring compliance with regulations, and maintaining relationships with international partners. Requires participation in health authority negotiations ...

Responsible for providing strategic direction and technical expertise for CMC regulatory activities. Prepares and oversees complex regulatory CMC submissions, collaborates with cross-functional teams, leads interactions with health authorities, and initiates process improvements. Coaches and mentors...

Provide regulatory leadership to clinical development programs in oncology, plan and coordinate regulatory submissions, establish effective relationships with cross-functional teams, manage direct reports, and maintain knowledge of the regulatory landscape in oncology.