Autonomybio

Autonomybio

Regulatory Lead / Head of Regulatory

San Francisco Office

Sponsorship not specified$20k-$70kDetected 474 days ago
FDA RegulatoryCollaborationAdaptability

About the role

  • This is a new paradigm focused on keeping healthy people healthy as opposed to treating individual diseases after they occur.
  • Read more in our Candidate Guide https://strong-transport-ceb.notion.site/Candidate-Guide-1a01fc245011803fbc7becb61ea1d52c?pvs=4.
  • By collaborating with global health authorities and pioneering novel endpoints, you'll help prove that keeping people healthy longer can, and should, be recognized as an official indication.

Responsibilities

  • Lead Accelerated Approval Pathways: Devise and refine strategies (Breakthrough Designation, Fast Track, Priority Review) for accelerated approval.
  • Champion Aging Endpoints: Engage directly with regulators to propose and validate new intermediate clinical endpoints or surrogate endpoints reasonably likely to predict aging clinical outcomes for aging-related studies.
  • Create Regulatory Contingency Paths: Establish backup plans for different jurisdictions, additional FDA requests, or unforeseen study requirements.
  • Engage Policy & Government Stakeholders: Initiate or support lobbying efforts to clarify aging endpoints and push for favorable FDA policy documents.
  • Regulatory Execution: Own major regulatory filings, meetings, and briefing documents, including innovative interactions such as Critical Path Innovation Meetings, COA program applications, and biomarker qualification pathways.
  • Unlocked Major Time Savings: Proposed at least 2-3 feasible shortcuts (e.g., concurrent CMC scale-up, adaptive trial designs) that compress timelines by 20-70%.
  • Built a Global Regulatory Network: Initiated contact with international regulatory agencies and leveraged multi-regional trial designs, securing potential "insurance" approvals outside the U.S.
  • Established a Comprehensive Patient Recruitment Strategy: Collaborated with Clinical Ops to build a large-scale participant database (e.g., 500k prospective volunteers).
  • Adept at proposing bold, out-of-the-box regulatory strategies that still maintain safety and compliance standards.
  • Willingness to "own" deliverables end-to-end without losing sight of big-picture impact.

Requirements

  • Comfort with ambiguous situations and ability to craft multiple viable solutions.

Nice to have

  • Successful IND/CTA Filings and direct involvement in key regulatory milestones (e.g., Type C, Pre-IND, or end-of-Phase 2 meetings).
  • Startup Experience (2+ years) or equivalent environment where adaptability and entrepreneurial initiative are highly valued.
  • Exposure to government/policy initiatives
  • Bachelor's Degree in Life Sciences, Pharmacy, or Related Field (advanced degree preferred).
  • Developed a 2-page position paper plus a "Plan B" in the event the FDA requests additional studies (e.g., juvenile toxicity).
  • Rapid Response Plans: Developed a 2-page position paper plus a "Plan B" in the event the FDA requests additional studies (e.g., juvenile toxicity).

Compensation

  • $20k-$70k

Benefits

  • Enabled Policy Influence: Advanced or joined an ad hoc lobbying/advocacy group, securing at least one policy document or FDA guidance clarification that benefits aging therapies.

Company info

  • We are an early-stage biotech company developing drugs with the goal of reducing multi-morbidity and earning an indication for aging, as opposed to the treatment of specific diseases. Our ultimate mission is to establish aging as a therapeutic area and empower humans with more time with loved ones and autonomy over their health. This is a new paradigm focused on keeping healthy people healthy as opposed to treating individual diseases after they occur.
  • As our Regulatory Lead / Head of Regulatory, you'll be at the forefront of creating a brand-new regulatory path. By collaborating with global health authorities and pioneering novel endpoints, you'll help prove that keeping people healthy longer can, and should, be recognized as an official indication.
  • We are an early-stage biotech company developing drugs with the goal of reducing multi-morbidity and earning an indication for aging, as opposed to the treatment of specific diseases.
  • Our ultimate mission is to establish aging as a therapeutic area and empower humans with more time with loved ones and autonomy over their health.
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