Head of Regulatory Affairs

Company: Roman Health Pharmacy LLC
Location: Redwood City
Posted on: June 1, 2025

Job Description:

Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan.We're building a mission-driven team of accomplished and kind individuals who embrace our startup culture of rapid iteration, transparency, and versatility.It's now time to fill a key leadership role at Retro to build and oversee global regulatory science and regulatory CMC strategic frameworks.This person will lead our regulatory efforts to help Retro advance from pre-IND to FDA approval, and help oversee and advance the lifecycle of all of Retro's therapeutics, acting as the bridge between Retro's internal research and future manufacturing and regulatory bodies. This person will report to the CEO and work closely with the therapeutic team leads.About you:You're fluidly intelligent - you understand the areas of research, manufacturing, and regulatory and can see how all the processes work together and what the key milestones are on the path to clinical stage Retro. You're a stellar communicator and know how to adjust as needed to collaborate with internal teams, external consultants, and regulatory agencies. You are well-organized, proactive, and adept at multitasking and managing pipelines.In this role, you will:

• Provide strategic guidance on regulatory requirements for cell and gene therapy and small-molecule CMC to support clinical trials and marketing applications.
• Build and lead the regulatory team (starting with contractors) and offer strategic input to accelerate product development and lifecycle management.
• Define and oversee the regulatory strategy for Retro's pipeline.
• Establish the regulatory path to BLA filing and approval for our programs.
• Contribute regulatory insights to key development documents, including clinical protocols, reports, and statistical analysis plans.
• Lead meetings with regulatory authorities and ensure timely submission of regulatory documents to keep programs on track.
• Identify and resolve strategic regulatory challenges, both routine and complex.
• Collaborate across CMC, nonclinical, and clinical research teams to keep stakeholders updated on new regulations and policies from global health authorities.
• Serve as the primary liaison with regulatory agencies like the FDA, EMA, and TGA.
• Develop and coordinate high-quality submissions for clinical trials.
• Strategize, draft, and oversee regulatory submissions for designations such as Orphan, Breakthrough, Fast Track, and Accelerated Approval to support development goals.You might thrive in this role if you have:
  • 10-15 years of experience in Cell & Gene Therapy and regulatory expedited development pathways.
  • The ability to navigate both the fast-moving, informal startup environment and the structured world of regulatory agencies.
  • Experience supporting both developmental programs and marketed products.
  • A background in IND & BLA submissions for stem-derived therapeutics, ideally including iPSC-derived products.
  • Experience managing regulatory teams.
  • Technical and regulatory expertise in developing autologous and off-the-shelf stem cell-based therapies for blood and brain disorders.
  • Knowledge of clinical development regulations, including protocol design, data analysis, and regulatory submissions (IND, NDA), and experience managing NDA reviews with regulatory authorities such as the FDA, TGA, and EMA.
  • A strong background in cell therapy development, manufacturing, and analytics.
  • Experience aligning regulatory strategies with clinical plans and business objectives.
  • Proven leadership in cross-functional collaboration, budgeting, and regulatory strategy across Preclinical Research, CMC, and Clinical teams.
  • The flexibility to adapt in a dynamic environment with diverse teams and communication styles.
  • The ability to clearly communicate regulatory strategies, issues, and risks to senior leadership and governing bodies.Salary: $225,000 - $300,000 a yearTotal compensation also includes generous equity and benefits, including:
    • Medical, dental, and vision insurance for you and your family.
    • 401(k) plan with 4% matching.
    • Unlimited time off and 10 company holidays per year.
    • Paid parental leave.
    • Annual learning & development stipend.
    • Daily company-sponsored lunch and snacks.We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.
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Keywords: Roman Health Pharmacy LLC, Union City , Head of Regulatory Affairs, Other , Redwood City, California