Director, Regulatory Affairs Jobs in Fremont, CA

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...

Lead strategic planning and execution of clinical research programs, managing multiple studies and partnerships with CROs and clinical sites to ensure adherence to regulatory standards and quality out...

Join as a leader in GCP quality oversight, guiding global clinical programs to ensure compliance and quality excellence. Drive risk management, enhance performance metrics, and support readiness for i...

Elevate global regulatory strategies as you lead cross-functional teams, ensuring compliance while driving market access for innovative products. Collaborate with stakeholders and health authorities t...

Execute R&D and Regulatory IT projects, ensuring compliance and timely delivery while leading cross-functional teams and managing system enhancements for optimal performance within budget constraints...

Provide comprehensive Regulatory Affairs support to ensure full compliance with U.S. FDA medical device regulations and international standards, facilitating product submissions and ongoing industry c...

Champion global regulatory strategies by leading diverse teams in navigating complex approval processes for medical devices. Drive compliance and ensure optimal product launch pathways while addressin...

Lead strategic regulatory consulting efforts for companion diagnostics, integrating insights across IVD development, clinical trials, and commercialization. Collaborate with stakeholders to ensure com...

Shape the future of GMP quality assurance by leading strategic initiatives, fostering a culture of compliance, and building a high-performing team to drive operational excellence across clinical and c...

Pioneer your compliance career by leading field compliance strategies that enhance organizational effectiveness while mitigating risks during product commercialization and expansion in a dynamic bioph...

Transform client relationships by serving as the primary contact for IRB review and advising designated pharmaceutical and academic partners, facilitating timely communications and process improvement...

Drive strategic non-clinical development by overseeing safety assessments, regulatory strategies, and cross-functional collaboration. Lead a team in advancing drug approval processes from discovery to...

Advance progress at the forefront of Medical Affairs by managing IME Grants and IST projects. Collaborate cross-functionally to optimize operations, drive process excellence, and support effective med...

Empower operational excellence by enhancing our Quality Management System (QMS), ensuring compliance with GxP and FDA standards. Lead cross-functional teams to drive quality assurance and regulatory r...

Lead the charge in driving innovative trade strategies across therapeutic areas, optimizing distribution channels, and delivering key insights that enhance profitability and access in a complex pharma...

Drive growth by selling impactful DMC services to clients within clinical trials. Leverage your sales expertise to collaborate with teams, enhance client relationships, and stay ahead of market trends...

Transform regulatory strategies to ensure compliance and facilitate product availability for innovative medical devices in domestic and international markets. Collaborate with teams to navigate comple...

Champion cross-functional collaboration to drive quality assurance practices and enhance product development. Lead Design Assurance initiatives, ensuring compliance with regulatory standards while men...

Transform global regulatory processes by leading approvals, strategizing submissions, and ensuring compliance for medical devices across diverse markets while collaborating with teams and serving as a...

Unlock potential by leading CMC QA strategy for diverse programs. Guide a high-performing team, ensuring compliance with global regulations while driving quality in biologics, gene therapy, and small...

Drive quality assurance for new product introductions in pharmaceuticals. Leverage leadership skills, manage cross-functional teams, and ensure regulatory compliance to deliver high-quality products e...

Lead the development and execution of a global compliance training strategy, enhancing organizational culture through engaging, risk-based programs that meet regulatory standards and industry best pra...

Shape your career by supporting regulatory compliance for clinical investigations and product distribution worldwide. Contribute to approvals and quality standards in a collaborative environment while...

Shape the future of cardiovascular therapy access by leading payer strategy and market entry initiatives. Join a dynamic biotech and build impactful partnerships that enable patient access to groundbr...

Grow your career with a pivotal role in Clinical QA, ensuring compliance and quality across clinical trials. Drive improvements, manage Quality Systems, and collaborate with teams to enhance operation...