Regulatory Affairs Manager Jobs in Fremont, CA

Manage regulatory submissions for US and Canada, guiding product development teams through compliance processes and collaborating globally to ensure successful product approvals and documentation exce...

Engage as a Global Regulatory Leader, driving innovative regulatory strategies and interactions to streamline product development and global approval processes, while ensuring compliance and effective...

Launch your career by supporting regulatory submissions and compliance activities, coordinating documentation, and engaging in team collaborations to drive successful outcomes in drug development and...

Pioneer regulatory excellence by leading FDA submissions and compliance. Manage the lifecycle of medical product filings, ensuring alignment with evolving regulations across diverse jurisdictions in a...

Drive regulatory excellence by leading a team to shape strategy and ensure compliance for innovative products. Collaborate with cross-functional teams to navigate approval pathways and maximize produc...

Partner with us to lead global regulatory affairs for innovative pharmaceutical products. Oversee strategy, team development, and agency negotiations while ensuring compliance and operational excellen...

Optimize regulatory operations by coordinating submissions, ensuring compliance, and collaborating with cross-functional teams. You'll empower the Regulatory Affairs department through effective commu...

Help us develop and execute global regulatory CMC strategies for investigational products while managing submissions and ensuring compliance with health authority requirements across cross-functional...

Champion the global regulatory strategy for complex CGT products, driving approval pathways and guiding cross-functional teams. Leverage your expertise in oncology and cell therapy to influence stakeh...

Elevate your career by leading global regulatory labeling strategies and initiatives. Oversee labeling governance, ensure compliance, and collaborate with cross-functional teams to support effective p...

Champion global regulatory activities, ensuring high-quality submissions and strategic partnerships. Support lifecycle management across late-stage development, driving compliance with U.S. and intern...

Join our dynamic team as you provide regulatory guidance and develop strategies for the Monarch Platform. Collaborate with cross-functional teams to ensure compliance, manage submissions, and shape th...

Lead the charge in building and nurturing strong relationships with healthcare practitioners, enhancing product adoption, and driving revenue growth through effective education and exceptional service...

Pioneer regulatory excellence by leading REMS strategies and compliance initiatives, driving collaboration across teams, and ensuring successful engagement with the FDA. Shape the future of patient sa...

Join a dynamic team as a Regulatory Affairs Specialist III, ensuring compliance with global regulations. Contribute strategically to product development and lifecycle management while collaborating ac...

Elevate your career as you ensure regulatory compliance in product development and manufacturing. Collaborate with project teams and guide submissions to domestic and international agencies while main...

Empower quality assurance in computerized systems by ensuring compliance with GxP regulations and driving best practices for data integrity, validation, and risk assessment in pharmaceutical and life...

Shape the future of regulatory affairs by owning CMC strategies across diverse programs. Engage with health authorities, lead cross-functional teams, and mitigate regulatory risks in a fast-paced envi...

Lead the establishment of a robust Product Quality function, enhancing governance and processes for evaluating lending products to ensure compliance, reliability, and accuracy across the financial ser...

Join a team that's shaping global regulatory strategies for innovative medical devices. Leverage your expertise in Software as a Medical Device (SaMD) to make impactful submissions and ensure complian...

Engage in leading GCP audit programs, managing staff development, and implementing quality initiatives to enhance safety compliance. Contribute to a dynamic, science-focused environment dedicated to i...

Lead and empower a team of regulatory compliance experts in supporting a ground-breaking healthcare platform, ensuring regulatory alignment and operational excellence within a complex, evolving enviro...

Join a team that drives regulatory strategy development and execution, ensuring high-quality submissions and compliance. Collaborate cross-functionally to manage complex regulatory deliverables with m...

Join a team that's passionate about advancing regulatory projects in the pharmaceutical industry. Drive compliance and ensure timely submissions while collaborating across functions, developing strate...

Grow your career with a dynamic team impacting surgery innovation. As a Senior Regulatory Affairs Specialist, you'll provide strategic regulatory guidance, ensuring compliance and supporting the devel...