Regulatory Lead / Head of Regulatory (Stealth Portfolio Company)

age1; San Francisco (CA); On-site; USD 85,000 - 180,000; Full time

Job summary

An innovative biotech company is seeking a Regulatory Lead to pioneer a new regulatory path in the field of aging. This role involves strategic planning, engaging with global health authorities, and creating regulatory frameworks that support the mission of enhancing human healthspan. The ideal candidate will have a strong background in regulatory affairs and a passion for advancing groundbreaking therapies. Join a forward-thinking team dedicated to making a significant impact on the future of healthcare and aging. This is an exciting opportunity to shape the regulatory landscape for novel therapies and drive meaningful change in the industry.

Qualifications

• 3+ years of regulatory experience in biotech/pharma.
• Hands-on interactions with FDA and global health authorities.
• Experience with IND/CTA filings and regulatory milestones.

Responsibilities

• Lead regulatory strategies for accelerated approval pathways.
• Engage with global regulators to validate new endpoints.
• Maintain regulatory scorecards and track activities.

Skills

Regulatory Strategy

Stakeholder Engagement

Clinical Development

Data Analysis

Policy Advocacy

Education

Bachelor’s Degree in Life Sciences

Advanced Degree in Related Field

Job description

Regulatory Lead / Head of Regulatory (Stealth Portfolio Company)

Join to apply for the Regulatory Lead / Head of Regulatory (Stealth Portfolio Company) role at age1

Regulatory Lead / Head of Regulatory (Stealth Portfolio Company)

3 weeks ago Be among the first 25 applicants

Join to apply for the Regulatory Lead / Head of Regulatory (Stealth Portfolio Company) role at age1

Get AI-powered advice on this job and more exclusive features.

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.

Why This Role Matters

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.

Key Responsibilities

Strategic Regulatory Planning

• Lead Accelerated Approval Pathways: Devise and refine strategies (Breakthrough Designation, Fast Track, Priority Review) for accelerated approval.
• Global Regulatory Insights: Investigate ex-U.S. regulatory bodies (EMA, MHRA, PMDA) to capitalize on faster approval processes or “regulatory arbitrage” opportunities.
• 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.
• Stakeholder Education: Translate complex regulatory requirements into clear, actionable steps for finance, R&D, investors, and other non-regulatory teams.
• Create Regulatory Contingency Paths: Establish backup plans for different jurisdictions, additional FDA requests, or unforeseen study requirements.
• Maintain Regulatory Scorecards: Implement real-time tracking of regulatory activities (meeting schedules, submission deadlines, emerging guidance changes) to keep leadership and investors informed.
• 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.
• Data & Biomarker Strategy: Collaborate with clinical, data science, and scientific teams to define, validate, and argue for new endpoints and biomarkers.

Measures of Success

Within the First 3–6 Months, You Will Have:

• Regulatory Roadmap for Accelerated Pathways: Drafted a memo comparing different potential arguments to make for intermediate clinical endpoints or surrogate endpoints reasonably likely to predict our aging clinical endpoints, detailing timelines, data demands, and potential ROI.
• Ex-US Approval Strategy: Specced out 3–4 jurisdictions that could grant faster approvals than the FDA, including market sizing and feasibility assessments.
• 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).
• Regulatory Scorecards: In collaboration with the COO created monthly dashboards for the CEO and board to monitor upcoming meetings, submission timelines, and potential risk points.

Within the First Year, You Will Have:

• 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%.
• Secured Alignment on Novel Endpoints: Obtained preliminary alignment (from the FDA or another major regulator) on one or more potential intermediate clinical endpoint or surrogate biomarker reasonably likely to predictour aging clinical endpoint.
• 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).
• 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.
• Cross-Functional Regulatory Knowledge:
• Expertise in global regulatory processes for novel therapies
• Creative and Ambitious Mindset:
• Adept at proposing bold, out-of-the-box regulatory strategies that still maintain safety and compliance standards.
• Resourceful in finding alternative pathways or lesser-known approval routes to accelerate timelines.
• Strong Ownership & Outcome Focus:
• Willingness to “own” deliverables end-to-end without losing sight of big-picture impact.
• Analytical Approach to Complexity
• Capable of quantifying the pros/cons of each regulatory decision under high uncertainty (time, cost, risk).
• Comfort with ambiguous situations and ability to craft multiple viable solutions.

Preferred Qualifications

• 3+ years of Regulatory or Clinical Development Experience in biotech/pharma, including hands-on interactions with the FDA and other global health authorities.
• Successful IND/CTA Filings and direct involvement in key regulatory milestones (e.g., Type C, Pre-IND, or end-of-Phase 2 meetings).
• Bonus: Previously helped a biotech secure an accelerated approval or full approval using a novel endpoint
• 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).

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Venture Capital and Private Equity Principals

Referrals increase your chances of interviewing at age1 by 2x

Sign in to set job alerts for “Regulatory Specialist” roles.

Alameda County, CA $100,000.00-$130,000.00 2 weeks ago

Alameda, CA $86,700.00-$173,300.00 1 month ago

San Francisco, CA $85,000.00-$90,000.00 2 weeks ago

San Francisco County, CA $140,000.00-$180,000.00 3 weeks ago

Principal Regulatory Affairs Specialist (Business Partnerships).

Manager/Senior Manager, Regulatory Affairs CMC

South San Francisco, CA $80.00-$135.00 2 weeks ago

Sr. Regulatory Document Formatting Specialist

Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)

Principal Regulatory Affairs Specialist – US New Product Introduction – Diabetes Care (on-site)

Alameda, CA $98,000.00-$196,000.00 5 months ago

Senior Corporate Counsel - Product & Regulatory

San Francisco, CA $220,000.00-$260,000.00 3 weeks ago

Quality Assurance Specialist, Financial Crimes

San Francisco, CA $40,000.00-$60,000.00 1 month ago

Regulatory Affairs Manager – APAC - Diabetes Care (on-site)

Small Molecules Regulatory Affairs CMC, Senior Manager

Emeryville, CA $72,417.00-$108,522.00 3 months ago

Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)

Alameda, CA $86,700.00-$173,300.00 3 months ago

Redwood City, CA $115,200.00-$172,800.00 5 days ago

Quality Assurance Specialist (Part-Time)

South San Francisco, CA $215,000.00-$248,000.00 19 hours ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.