Regulatory Lead / Head of Regulatory

Job description

ABOUT US 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. Read more in our Candidate Guide https://strong-transport-ceb.notion.site/Candidate-Guide-1a01fc245011803fbc7becb61ea1d52c?pvs=4. 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 - 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. - 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. SUCCESS MEASURES WITHIN THE FIRST 3–6 MONTHS, YOU WILL HAVE: 1. 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. 2. Ex-US Approval Strategy: Specced out 3–4 jurisdictions that could grant faster approvals than the FDA, including market sizing and feasibility assessments. 3. 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). 4. 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: 1. 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%. 2. 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 predict our aging clinical endpoint. 3. 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. 4. Established a Comprehensive Patient Recruitment Strategy: Collaborated with Clinical Ops to build a large-scale participant database (e.g., 500k prospective volunteers). 5. 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. REQUIRED SKILLS & COMPETENCIES 1. Cross-Functional Regulatory Knowledge: - Expertise in global regulatory processes for novel therapies 2. 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. 3. Strong Ownership & Outcome Focus: - Willingness to “own” deliverables end-to-end without losing sight of big-picture impact. 4. 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).