Director, Regulatory Affairs Jobs in Alameda, CA

Join a dynamic team to navigate regulatory processes for medical devices, develop strategies for U.S. and Canadian markets, and lead submissions. Collaborate with cross-functional teams to ensure comp...

Drive regulatory excellence by leading global submissions, advising cross-functional teams, and shaping compliance strategies to ensure successful market access for innovative products in highly regul...

Lead the charge in advancing global quality monitoring and compliance efforts, ensuring governance and continuous improvement within the Quality Management System, driving inspection readiness, and fo...

Join a team that's dedicated to enhancing clinical quality through effective GCP oversight and audits, supporting clinical studies and ensuring compliance while mentoring the next generation of QA pro...

Join a team that's dedicated to advancing regulatory strategies for innovative SaMD products. Collaborate cross-functionally to drive compliance, manage documentation, and ensure readiness for audits...

Collaborate with key stakeholders to shape CMC regulatory strategies that drive timely approvals and ensure compliance, while training and mentoring a dynamic regulatory affairs team...

Drive strategic CMC regulatory submissions and develop relationships within product teams to ensure successful and timely delivery of pharmaceutical products to patients. Contribute to meeting regulat...

Drive regulatory strategies for CMC, ensuring timely approvals through collaboration and influence. Manage submissions and engage with agencies to navigate complex pharmaceutical landscapes while lead...

Drive regulatory submission strategies and oversee CMC content preparation. Collaborate with teams to ensure compliance and efficiency, influencing outcomes with regulatory authorities. Provide mentor...

Champion business growth by overseeing client relationships and sales strategies. Engage with key accounts, analyze opportunities, and lead the sales process to drive success in the healthcare sector...

Accelerate progress at the forefront of bioassay development, leading a skilled team in developing sophisticated potency and impurity assays for protein biologics. Drive strategy across early to late...

Discover new opportunities in a dynamic role where you will lead projects, collaborate with diverse teams, and drive innovative solutions that impact the organization positively and enhance operationa...

Lead the charge in GMP API Quality Assurance, overseeing compliance and performance management with external manufacturers. Collaborate cross-functionally to ensure inspection readiness and support a...

Lead the charge in ensuring GMP manufacturing compliance through QA oversight, risk assessment, and productive cross-functional collaboration. Guide CMC operations while maintaining high standards for...

Transform environmental excellence by leading a high-performing team and ensuring compliance across our dynamic pharmaceutical campus. Drive sustainability initiatives and collaborate with senior lead...

Elevate regulatory practices by leading strategic initiatives for endovascular medical devices, ensuring compliance and approvals across product lifecycles while collaborating with cross-functional te...

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

Lead the charge in developing innovative regulatory strategies and submissions for diabetes care products. Utilize your expertise to navigate global regulatory landscapes and drive compliance across p...

Drive innovative access strategies for oncology diagnostics, shaping payer engagements to enhance patient adoption and reimbursement efficacy globally. Collaborate with cross-functional teams to integ...

Champion regulatory excellence in food safety and nutrition, leveraging deep expertise to guide clients through complex compliance challenges and develop impactful strategies for product approvals and...

Join a dynamic team to drive manufacturing and operational plans ensuring compliance, quality, and efficiency for commercial and clinical products. Collaborate with leadership to improve processes and...

Innovate global communications strategies for obesity treatments by partnering with diverse teams, driving impactful narratives, and executing plans that enhance development and launch. This role requ...

Champion recall operations by managing teams, executing FDA-compliant strategies, and driving cross-functional alignment to ensure timely product corrections and removals while maintaining regulatory...

Elevate clinical pharmacology strategy for cardiovascular development, leading cross-functional collaboration and ensuring regulatory submission excellence. This role demands strategic vision and exec...

Lead data governance and FAIR practices to drive analytics, AI innovation, and data strategy across the enterprise. Collaborate with cross-functional teams to establish scalable data management framew...