Manager / Senior Manager, Global Regulatory Affairs, Lifecycle Management (Los Altos)

What you'll do

• Define correct platform outputs, create reference cases and acceptance criteria, review AI outputs, and work with Product and Engineering on improvements.
• Onboard customers, prepare account inputs, review deliverables, answer regulatory questions, and participate in customer meetings and on-site sessions.
• Apply regulatory expertise to lifecycle filings and content, resolve or escalate ambiguous cases, and keep platform rules current as guidance changes.

What they ask for

• At least 5 years in regulatory affairs, including at least 3 years in post-approval lifecycle management, in pharma, biotech, a CDMO or a regulatory services company.
• Hands-on registration maintenance across markets and post-approval filing experience in the US and EU.
• Personal authorship of regulatory CMC content, plus documented judgment on ambiguous or conflicting requirements.
• Experience with at least one biologic or other complex product; working knowledge of ICH Q12, Q5E, Q5C, Q1A(R2)/Q1E and Q2(R2)/Q14.

Nice to have

• Post-approval filing beyond the US and EU, health-authority interaction, regulatory intelligence or innovation work, or AI-assisted regulatory workflows.
• RAC; Veeva Vault RIM, eCTD or structured labeling (SPL, ePI); CSV or CSA exposure; CCDS and local label maintenance; multi-market company experience; Korean- or Japanese-language regulatory documents.

Pay

$150,000 – $185,000 (base salary, Manager level); $180,000 – $220,000 (base salary, Senior Manager level)

Tools

Veeva Vault RIM, eCTD, SPL, ePI, CSV, CSA

AI focus

Reviews and validates AI-generated regulatory drafts and assessments, defines acceptance criteria, and captures expert reasoning to improve the platform. Prior AI experience is helpful but not required; no coding is required.