Manager / Senior Manager, Global Regulatory Affairs, Lifecycle Management (Los Altos)
About The Position
Cheiron is building AI software for pharmaceutical regulatory lifecycle management and is working with its first pilot customers. The platform tracks product registrations, approved states, commitments, conditions, and required filings across markets; assesses the regulatory impact of proposed manufacturing or quality changes; and drafts and checks regulatory documents. Customers retain their regulatory records and qualified staff make formal decisions, with Cheiron supporting their work. The Manager / Senior Manager will serve as a hands-on global regulatory affairs expert on the Life Sciences team, applying regulatory judgment across the registered life of products, from routine maintenance through cases not resolved by guidance. The role owns assigned customer-account work within agreed scopes and divides time approximately evenly between customer delivery and reusable content, validation, and product improvement. Difficult cases are documented and proposed to the Associate Director of Regulatory Affairs, who is the team's senior regulatory authority and makes final calls. At Senior Manager level, the role also structures ambiguous cross-functional work and leads difficult customer discussions. This is an individual-contributor position with no direct reports and reports to the Head of Life Sciences. The position is based in person in Los Altos in the Bay Area and includes travel within the US to customer sites. The role collaborates with Product and Engineering, supports customer regulatory teams, authors and reviews regulatory content, monitors guidance changes, and helps ensure that platform outputs and reference materials remain accurate and current.
Requirements
- At least 5 years of regulatory affairs experience, 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, including renewals, annual reports, and tracking commitments and conditions.
- Post-approval filing experience in the US and EU, such as Prior Approval Supplements, CBE-30 and CBE-0 supplements, annual reports, and EU Type IA, IB, and II variations; understanding of how requirements and timelines differ in other markets.
- Personal authorship of regulatory CMC content, including Module 3 sections, quality summaries, change justifications, and contributions to health-authority responses.
- Demonstrated judgment in ambiguous cases, including examples of resolving or escalating unclear or conflicting requirements and documenting the reasoning.
- A validation mindset and experience setting review standards, QC checks, or acceptance criteria, with disciplined verification of technical text, including AI-generated drafts.
- Experience with at least one biologic or other complex product.
- 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 Haves
- Post-approval filing experience beyond the US and EU, such as Japan, Korea, Canada, or reliance markets, and health-authority interaction.
- Regulatory intelligence or regulatory innovation work, or experience with AI-assisted regulatory workflows.
- Experience with CCDS and local label maintenance, artwork change control, or safety-driven label updates.
- Exposure to computerized-system validation (CSV or CSA).
- RAC credential; experience with Veeva Vault RIM, eCTD, or structured labeling (SPL, ePI).
- Experience at a multi-market company (biosimilar, generics, or licensing), or experience with Korean- or Japanese-language regulatory documents.
- Prior AI experience; it is helpful but not required.
Responsibilities
- Work with Product and Engineering to define how the platform handles registration maintenance, post-approval changes, and regulatory documents.
- Define correct regulatory outputs, write reference cases and acceptance criteria, review platform outputs, and turn defects into specific issues with acceptance checks.
- Onboard customer regulatory teams and prepare their account inputs.
- Review platform outputs before customer delivery, answer customer regulatory questions, and participate in customer meetings and on-site sessions.
- Explain to customers what the platform supports, what is conditional, and who needs to act.
- Apply regulatory experience with renewals, annual reports, commitments, variations and supplements, Module 3 content, and health-authority responses to author and check platform and customer-facing content.
- Analyze cases where guidance is silent, sources conflict, or markets diverge; document reasoning, propose a position, and escalate to the Associate Director of Regulatory Affairs.
- Track regulatory guidance changes across markets and update platform rules and reference cases accordingly.
- At Senior Manager level, structure ambiguous cross-functional work and lead difficult customer discussions.
Benefits
- Medical, dental, and vision benefits.
- 401(k).
- Meal allowance for lunch and dinner.
- Transportation support for early starts and late nights.
- In-office snack bar.
- Visa sponsorship available.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
