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

Cheiron•Los Altos, CA

12d•Onsite

About The Position

Cheiron is building AI software for regulatory lifecycle management in the pharmaceutical industry. Its platform tracks what is registered in each market, including approved states, commitments, conditions, and filings needed to keep registrations current. It also assesses the market implications of proposed manufacturing or quality changes and drafts and checks regulatory documents. Customers retain their regulatory records and qualified staff make formal decisions; Cheiron supports their work. The role is 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 cases not settled by guidelines. The person owns work for assigned accounts within agreed scopes and works alongside AI that produces drafts, assessments, and checks. Approximately half the time is spent on customer delivery and half on reusable content, validation, and product improvement. At Senior Manager level, the role also structures ambiguous cross-functional work and leads difficult customer discussions. It is an individual-contributor role with no direct reports. The role reports to the Head of Life Sciences; the Associate Director of Regulatory Affairs is the team's senior regulatory authority and makes final calls on escalated hard cases. The position is based in person in Los Altos in the Bay Area, with travel within the US to customer sites. The hiring process includes application review and written questions, conversations with the Head of Life Sciences and CEO, a working session using fictional materials, and references and offer. The company aims to reach an offer within about three weeks. Visa sponsorship is available.

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, including experience setting review standards, QC checks, or acceptance criteria, and 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 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, such as a biosimilar, generics, or licensing company, or with Korean- or Japanese-language regulatory documents.

Responsibilities

Work with Product and Engineering on how the platform handles registration maintenance, post-approval changes, and regulatory documents.
Define correct platform outputs, write reference cases and acceptance criteria, review outputs, and turn defects into specific issues with acceptance checks.
Onboard customer regulatory teams, prepare account inputs, review outputs before delivery, answer regulatory questions, and participate in customer meetings and on-site sessions.
Clearly explain to customers what the platform supports, what is conditional, and who needs to act.
Apply hands-on expertise with renewals, annual reports, commitments, variations and supplements, Module 3 content, and health-authority responses to author and check platform and customer 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 guidance changes across markets and keep the platform's rules and reference cases current.
At Senior Manager level, structure ambiguous cross-functional work and lead difficult customer discussions.