Senior Regulatory Affairs Specialist Jobs in Pleasanton, CA

Drive compliance initiatives to ensure product safety and adherence to global regulations. Engage in regulatory submissions, manage changing environments, and represent the organization in regulatory...

Champion regulatory compliance by supporting quality processes and product lifecycle management in the medical device sector, ensuring adherence to standards during design, development, and commercial...

Champion global regulatory strategies for medical devices, ensuring compliance from development through market approval. Collaborate cross-functionally to assess compliance and support international e...

Reimagine Regulatory Affairs by leading complex outsourcing programs and driving client success. Utilize deep expertise in strategy and operations to manage projects, mentor teams, and deliver tailore...

Drive regulatory excellence by shaping compliance strategies for medical robotics. Collaborate across teams to manage submissions, enhance processes, and mentor talent while navigating complex regulat...

Accelerate product success by leading regulatory initiatives from development to commercialization, ensuring compliance with FDA and international standards, while mentoring teams and making strategic...

Innovate and execute regulatory CMC strategies for radiopharmaceutical products, ensuring compliance across global markets. Collaborate with cross-functional teams to support submissions and enhance p...

Join a team that's shaping regulatory strategies in biopharmaceuticals. This role involves leading regulatory submissions and collaborating across project teams to ensure compliance while advancing co...

Lead the charge in regulatory submissions for EU and ex-U.S. markets, managing CTA preparation and execution, while collaborating across teams to ensure compliance and timely approvals in a fast-paced...

Join a team dedicated to transformative regulatory compliance, focusing on EU and ex-U.S. clinical trial applications. Lead critical submission strategies and foster collaboration across functions to...

Unlock potential by driving continuous improvement of our global GxP Document Management Program. Oversee document control processes, ensuring compliance with industry standards while collaborating ac...

Join our team to support regulatory efforts for innovative biologics while collaborating across functions to maintain compliance, manage submissions, and ensure adherence to global standards in a fast...

Lead regulatory efforts to advance innovative biologics, collaborating with cross-functional teams and health authorities. Drive global regulatory strategies and ensure high-quality submissions while...

Lead the charge in regulatory strategy for innovative surgical technologies, collaborating cross-functionally to achieve global market access and support product development within a dynamic and growt...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

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...

Lead critical clinical strategies and ensure regulatory compliance while collaborating across teams to uphold data integrity and support product development initiatives in a dynamic environment...

Drive the enhancement of GxP training programs in Quality Systems, ensuring compliance with regulatory standards. Collaborate across functions to assess training needs, design effective curricula, and...

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...

Lead supplier engineering initiatives, ensuring quality and delivery efficiency while driving improvements across manufacturing processes, risk analysis, and supplier relations to meet organizational...

Optimize CMC regulatory strategies for biologic products across the product lifecycle. Lead cross-functional teams to ensure compliance with global regulatory standards while driving successful submis...

Execute quality assurance processes to ensure timely product releases and compliance with regulatory standards, while collaborating with cross-functional teams to resolve nonconformance issues effecti...

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...

Transform clinical trial management by maintaining essential documents and trackers, ensuring compliance with regulations, and supporting study teams throughout trial phases. Contribute to efficient o...

Strategize impactful lifecycle regulatory strategies for radiopharmaceuticals, leading a global team to optimize compliance, drive submissions, and ensure seamless cross-functional collaboration while...