Director, Regulatory Affairs Jobs in Alameda, CA

Champion quality excellence by leading Quality and Regulatory functions, ensuring compliance with global standards while driving a culture of operational excellence and continuous improvement across p...

Engage with cross-functional teams to ensure regulatory compliance for Expanded Access Programs. Drive essential strategies and submissions while staying aligned with global legislation, impacting pat...

Transform the biopharmaceutical landscape by advising clients on regulatory compliance and clinical pharmacology strategies, leveraging your expertise to impact innovative drug development across dive...

Shape the future of regulatory affairs by leading strategic initiatives for product approval in the US and Canada. Manage complex submissions, collaborate with cross-functional teams, and interface wi...

Lead cross-functional collaboration to establish regulatory strategies for drug development, ensuring compliance with ICH guidelines and global health authority requirements throughout product lifecyc...

Unlock compliance potential by leading field strategy for Commercial and Medical teams, ensuring adherence during product launches and expansions while fostering collaboration across stakeholders to s...

Lead and manage a global Pharmacovigilance audit program, ensuring compliance with regulations and industry best practices. Collaborate with cross-functional teams to enhance processes and drive conti...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

Join our team to lead regulatory strategies across major programs, driving impactful submissions and fostering collaboration within a challenging and dynamic environment. Embrace the opportunity to in...

Champion operational excellence and strategic partnerships in the clinical research space. Drive financial performance and enhance client satisfaction while leading high-performing teams to achieve su...

Lead the charge in ensuring quality oversight, compliance, and product complaint management. Drive CAPA program effectiveness and inspection readiness while collaborating with cross-functional teams t...

Lead the charge in managing and directing CMC regulatory strategies, overseeing critical projects across multiple therapeutic areas, and ensuring compliance with global regulatory standards while enga...

Transform regulatory writing by leading complex submissions, mentoring teams, and ensuring compliance. Drive innovation and improve processes while collaborating across teams to enhance product succes...

Elevate our global labeling strategy by leading end-to-end processes, driving compliance, and optimizing product positioning through precise, defensible labeling language while collaborating across te...

Bring your expertise to a dynamic team as you lead high-impact medical content development. Collaborate cross-functionally, mentor talent, and strategize with clients to enhance medical education and...

Join a team that's leading the way in Global Patient Safety Operations. Drive strategic oversight for pharmacovigilance operations, managing compliance and quality while developing a high-performing t...

Drive quality assurance and compliance for small molecule DS and DPI production, ensuring inspection readiness and oversight of manufacturing processes, validations, and regulatory submissions while c...

Champion global access programs for innovative cancer therapies, ensuring alignment with clinical, regulatory, and patient needs. Lead cross-functional teams to enhance early access strategy and opera...

Lead the charge in ensuring quality compliance by conducting thorough GMP and GDP audits across Gilead’s global manufacturing and supply network, enhancing internal policies and external partnerships...

Drive global CMC regulatory strategies and submissions for clinical and commercial products. Collaborate cross-functionally to ensure compliance, lifecycle management, and timely delivery of high-qual...

Reimagine global compliance strategies as you guide regulatory submissions, assess product impacts, and collaborate across teams to ensure adherence to medical device regulations while enhancing quali...

Empower quality excellence by leading complaint management and CAPA programs, ensuring compliance, driving improvement, and fostering collaboration across functions to enhance product safety and effec...

Drive insurance regulatory engagement and filing processes, ensuring timely and accurate submissions. Partner with cross-functional teams to translate analytical outputs into regulator-ready materials...

Drive compliance and legal support for regulatory affairs, guiding teams through complex healthcare laws while leading a high-performing legal group to enhance operational efficiency and navigate legi...

Lead the Vacaville MSAT department, driving operational excellence, compliance, and team development to meet strategic objectives and foster a high-performing culture. Champion collaboration across de...