Regulatory Affairs Manager
The Regulatory Affairs Manager at Intuitive will lead the strategy and execution of regulatory submissions for drug products, ensuring compliance with FDA and international standards. This role encompasses the entire chemistry, manufacturing, and controls (CMC) lifecycle, from early-stage development through post-market changes. The position is based in Sunnyvale, California, and is fully onsite.
Key responsibilities include compiling, writing, and submitting comprehensive dossiers (INDs, NDAs) for product approvals and licenses. The manager will also oversee CMC-specific regulatory activities, such as reviewing manufacturing changes and site transfers to ensure global compliance. Serving as the primary point of contact for the FDA, EMA, and other health authorities, the manager will manage formal meetings and respond to information requests. Collaboration with R&D, Quality, and Marketing teams is essential to provide strategic regulatory input on product development and manufacturing scale-up. Additionally, the role involves overseeing internal audits, inspections, and renewals to ensure adherence to current regulations.
Candidates should have a minimum of 8 years of experience in Regulatory CMC, with a deep understanding of drug substance and drug product manufacturing. Experience managing Outside the United States (OUS) submissions, particularly for the EU (EMA) and other major global markets, is required. Direct experience navigating US state-level regulatory requirements, such as wholesale distributor licenses and state manufacturing permits, is also necessary. Hands-on experience managing products with Fast Track and/or Breakthrough Therapy designations is preferred. Familiarity with the technical aspects of submission management, including eCTD software and global submission standards, is important. A Bachelor’s degree in a scientific or healthcare field is required; an advanced degree (MS, PhD, or PharmD) or Regulatory Affairs Certification (RAC) is preferred.
The compensation for this role ranges from $128,900 to $218,300 annually, depending on experience and qualifications. Intuitive offers a comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, with a mission to make surgery smarter, safer, and more human. The company fosters a culture of inclusion and diversity, encouraging team members to bring their authentic selves to work. Employees are empowered to contribute to meaningful work that has the potential to change lives, with opportunities for growth and advancement within the organization.