Senior Regulatory Affairs Specialist Jobs in Irvine, CA

Lead global regulatory strategies for oncology programs, ensuring compliance and effectively interacting with regulatory agencies for product approvals in late-stage development...

Join a team that's advancing regulatory strategies for drug substance manufacturing. Lead the charge in selecting and justifying Regulatory Starting Materials, ensuring compliance with global guidelin...

Unlock potential by driving regulatory submissions and managing documentation. Collaborate with global teams to align on strategies, ensuring compliance and effective communication while fostering a c...

Support the Quality Management System by reviewing and approving key documentation, ensuring compliance with regulations. Champion best practices in discrepancy reporting and CAPA processes while coll...

Lead global strategy for Notified Body engagement, ensuring compliance, managing audits, and driving certification readiness across various jurisdictions. Guide integration assessments, enhance proces...

Elevate quality assurance standards by implementing improvements, conducting audits, and ensuring GMP compliance. Collaborate across teams to enhance processes and lead initiatives that foster a cultu...

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...

Champion regulatory excellence by ensuring hospital compliance with standards, conducting audits, and fostering collaboration with clinical leaders to uphold accreditation and quality care across all...

Elevate the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...

Drive global CMC strategy for transformative cell and gene therapies, ensuring seamless regulatory pathways and efficient product approvals through collaborative leadership and strategic risk manageme...

Accelerate regulatory strategy development for oncology products, leading global initiatives to secure IND/CTA approvals and marketing applications. Collaborate with cross-functional teams to navigate...

Champion regulatory excellence by leading postmarket strategies for product compliance, driving collaboration across teams to ensure timely submissions and navigate complex regulatory landscapes for c...

Drive quality excellence by leading QMS activities and continuous improvement initiatives. Collaborate cross-functionally to maintain compliance and enhance quality systems, ensuring a robust QMS fram...

Contribute to regulatory excellence by coordinating U.S. submissions, ensuring compliance with FDA standards, and maintaining vital documentation for the Obesity Therapeutic Area, while collaborating...

Empower global market growth by leading regulatory strategies for companion diagnostics. Collaborate with cross-functional teams and ensure compliance with various regulatory submissions while managin...

Unlock your potential by overseeing site management and monitoring for clinical trials, ensuring compliance with regulations and enhancing site relationships to drive quality and timely delivery of cl...

Lead end-to-end GCP audits globally, ensuring compliance and driving improvements in clinical studies. Collaborate with stakeholders to interpret regulations and support regulatory inspections in a dy...

Transform compliance processes by leveraging regulatory expertise to ensure adherence with internal and external standards across operations. Drive quality initiatives while promoting effective collab...

Join a team that ensures compliance with regulatory standards across various healthcare operations. Leverage your expertise to navigate complex regulatory landscapes and enhance the organization's com...

Innovate the future of regulatory labeling by driving strategies across global teams, ensuring compliance and quality at all stages of product development while collaborating with key stakeholders to...

Lead the charge in developing supplier quality processes that ensure reliability in satellite manufacturing. As the first quality-focused engineer, you will shape foundational quality systems, engagin...

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

Lead global regulatory strategy for high-complexity cell therapies, ensuring competitive pathways to approval. Collaborate with cross-functional teams and influence health authority dialogue for patie...

Champion the validation of cutting-edge lab instrumentation while collaborating with diverse teams to ensure customer readiness and operational excellence. Your expertise will drive quality and compli...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...