"Bring hands-on regulatory judgment to AI that runs the registered life of a product."
• About the RoleYou will work alongside AI that produces first drafts, assessments and checks. Your judgment decides what is right, and your work makes the system better. You will be the hands-on global regulatory affairs expert on a growing Life Sciences team, responsible for regulatory correctness across the registered life of a product, from routine maintenance to the cases the guidelines do not settle.
You own the work for your assigned accounts within agreed scopes. Our Associate Director of Regulatory Affairs is the team's senior regulatory authority: you document hard cases, propose a position and escalate, and the Associate Director makes the final call. Expect roughly half your time on customer delivery and half on reusable content, validation and product improvement. At Senior Manager level you also structure ambiguous cross-functional work and lead difficult customer discussions; level reflects demonstrated scope and independence.
This role reports to the Head of Life Sciences. It is an individual contributor role with no direct reports.
• What You'll Do- Build the product with us. Work with Product and Engineering on how the platform handles registration maintenance, post-approval changes and regulatory documents. Define what a correct answer looks like, write reference cases and acceptance criteria, review outputs, and turn defects into specific issues with an acceptance check.
- Support customers. Onboard customer regulatory teams, prepare their account inputs, review outputs before delivery, answer their regulatory questions, and join customer meetings and on-site sessions. Explain clearly what is supported, what is conditional, and who needs to act.
- Bring hands-on regulatory expertise. Apply your experience with renewals, annual reports, commitments, variations and supplements, Module 3 content and health-authority responses to author and check the content the platform and our customers rely on.
- Work through the edge cases. Where guidance is silent, sources conflict or markets diverge, set out the reasoning, propose a position and bring it to the Associate Director, and capture that reasoning so the platform learns from it.
- Keep it current. Track guidance changes across markets and make sure the platform's rules and reference cases follow them.
• What We're Looking 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: renewals, annual reports and tracking commitments and conditions. You can name the things that tend to slip.
- Post-approval filing experience in the US and EU (for example Prior Approval Supplements, CBE-30 and CBE-0 supplements and annual reports; EU Type IA, IB and II variations), and an understanding of how requirements and timelines differ in other markets.
- Personal authorship of regulatory CMC content: Module 3 sections, quality summaries, change justifications and contributions to health-authority responses. We will ask what you wrote, not only what you coordinated.
- Judgment on ambiguous cases: examples of resolving or escalating unclear or conflicting requirements, with the reasoning written down.
- A validation mindset: experience setting review standards, QC checks or acceptance criteria, and disciplined verification of technical text, including AI-generated drafts. Prior AI experience helps but is not required; no coding is required.
- Experience with at least one biologic or other complex product, and working knowledge of ICH Q12, Q5E, Q5C, Q1A(R2)/Q1E and Q2(R2)/Q14.
- Clear written and spoken English, and comfort discussing uncertainty directly with customers.
- A degree in pharmaceutical sciences, pharmacy, chemistry, biochemistry, biotechnology or a related field, or equivalent experience.
• Nice to Have- Post-approval filing beyond the US and EU (for example Japan, Korea, Canada or reliance markets), and health-authority interaction.
- Regulatory intelligence or regulatory innovation work, or AI-assisted regulatory workflows.
- CCDS and local label maintenance, artwork change control, or safety-driven label updates.
- Exposure to computerized-system validation (CSV or CSA).
- RAC; Veeva Vault RIM, eCTD or structured labeling (SPL, ePI).
- Experience at a multi-market company (biosimilar, generics or licensing), or with Korean- or Japanese-language regulatory documents.
• Hiring ProcessApplication review > Head of Life Sciences > Working session > CEO > References and offer
- Application review with two short written questions (non-confidential examples only).
- A 30-minute conversation with our Head of Life Sciences.
- A 90-minute working session with the Head of Life Sciences and the Associate Director on a fictional product. You get a short source pack two business days ahead; reading it is the only preparation. You will work through a registration and change scenario that includes a commitment coming due and a point the guidance does not settle, write a short passage without generative AI, review an AI-generated draft, and explain next steps to a fictional customer. AI is optional elsewhere, and we provide access.
- A 30-minute conversation with our CEO.
- References (with your permission) and offer.
About 3 hours 15 minutes in total, with no take-home work. Exercise materials are fictional, and your work is used only for hiring. We aim to reach an offer within about three weeks.
• Compensation and Terms- The base salary range for this position is $150,000 - $185,000 at Manager level and $180,000 - $220,000 at Senior Manager level. Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by factors including job-related skills, experience, and relevant education or training.
- Part-time: pay is pro-rated from the full-time range based on agreed hours.
- Benefits: Medical, Dental, Vision, and 401(k); meal allowance (lunch, dinner); transportation support for early starts and late nights; in-office snack bar. Details in offer.
- Visa sponsorship available.
- Location: Bay Area (Los Altos), in person, with travel within the US to customer sites.
