Head of Regulatory Affairs

Head of Regulatory Affairs

Requirements

• 10-15 years of experience in Cell & Gene Therapy and regulatory expedited development pathways.
• 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 ability to clearly communicate regulatory strategies, issues, and risks to senior leadership and governing bodies.

Responsibilities

• 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.

Preferred Qualifications

• The ability to navigate both the fast-moving, informal startup environment and the structured world of regulatory agencies.
• The flexibility to adapt in a dynamic environment with diverse teams and communication styles.