Senior Regulatory Affairs Specialist Jobs in San Diego, CA

Join us to drive quality assurance in GMP/GDP auditing, ensuring compliance and inspection readiness across our partner network. Collaborate with cross-functional teams to enhance supplier qualificati...

Join a dynamic team focused on executing GMP/GDP audits and ensuring compliance across suppliers. Collaborate with cross-functional partners to maintain high-quality standards and drive continuous imp...

Shape the future of regulatory strategy by leading cross-functional teams, driving innovative development strategies, and providing regulatory thought leadership to ensure compliance and accelerate pr...

Lead the charge in developing global regulatory strategies for clinical programs. Manage regulatory operations for product lifecycle while collaborating with cross-functional teams to ensure successfu...

Lead the charge in transforming GMP QC systems with exceptional project management skills. Oversee integration, collaborate with teams, ensure compliance, and drive system readiness. Your expertise wi...

Join a team that's shaping the future of regulatory project management in biotech. Lead global regulatory affairs activities to ensure compliance and drive successful submissions for rare disease ther...

Oversee global regulatory project management for rare disease therapies, ensuring alignment with strategic goals and health authority compliance. Collaborate cross-functionally to create timelines and...

Inspire excellence in CMC regulatory leadership for biologics. Drive global strategies, ensure compliance, and foster cross-functional collaboration to advance product development and lifecycle succes...

Shape the future of medical devices by leading regulatory strategies, ensuring compliance across global markets, and mentoring a dedicated team. Empower innovation through effective communication with...

Collaborate with cross-functional teams to oversee regulatory activities for a portfolio of Pharmaceutical Diagnostics products, ensuring compliance and strategic alignment with global standards throu...

Lead regulatory compliance programs ensuring inspection readiness and proactive risk management across cross-functional teams. Monitor compliance health, manage data quality, and drive improvements al...

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...

Unlock potential by leading quality oversight in medical device development, ensuring compliance with industry standards, and driving risk management strategies for successful product launches and con...

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...

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...

Join a team that drives innovative CMC regulatory strategies for global cell therapy products and supports cross-functional collaboration while ensuring compliance with evolving standards...

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...

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...