Head of Regulatory Affairs - Verismo Therapeutics : Job Details

Head of Regulatory AffairsFull-Time positionLevel: Senior Director/Director/ AD, Regulatory AffairsLocation: Hybrid In-office/remote combination (Philadelphia, PA)Start date: Available immediatelyWhy Join Verismo? Our team is small but driven, with the single focus of bringing life-changing cell therapies to patients with cancer. With a solid pipeline built around the novel KIR-CAR platform, and two clinical trials underway, our technology has found a way to circumvent the barriers in solid cancer where other CAR therapies have had limited success. KIR-CARs eliminate the artificial recombinant chimeric receptors used in CAR T cells and instead use a natural NK cell derived signaling system. This system is potent against both hematologic and solid tumors, and in preclinical models is superior to current CAR T in conferring long-term, sustained anti-tumor function to overcome T cell exhaustion. We have a strong team for CMC with PD and AD, clinical product manufacture, and lead clinical investigators bringing KIR-CARs to patients in need. Our company is comprised of individuals who each bring something unique to the table and are valued for their contributions. Our culture is based on the concept of 'love what you do' and the dedication that builds a team where people do their best and support one another. Because we believe our people are our greatest asset, career development is an encouraged as an investment in our team and we encourage a healthy work/life balance. About the Position: Verismo Therapeutics is seeking a motivated and experienced Senior Director/Director/AD of Regulatory Affairs to join our energetic and high-growth team. This position will be heavily weighted on CMC compliance, with specific focus on comparability and change processes from early to later-phase clinical trials. This individual will report directly to our Chief Operations Officer. The position will be responsible for shaping and executing Verismo's regulatory strategy across pipelines and markets. This includes driving integrated regulatory plans that align CMC, non-clinical, and clinical programs from early development through registration. The role will require hands-on drafting, editing, and submission of filings, and close collaboration with cross-functional teams - including process development, quality, and manufacturing - to ensure regulatory compliance and readiness. Essential Duties & Responsibilities:

• Develop, implement, and advise on regulatory strategies through all phases of development.
• Interface with National and International Health Authorities, as appropriate, regarding development, regulatory, and registration strategies. Provide innovative and proactive regulatory leadership to project teams that aligns with development plans and corporate goals.
• Coordinate regulatory activities for global clinical trials, ensuring alignment of submission packages across different regions and regulatory frameworks.
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
• Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, and so on to ensure compliance with relevant regulations and guidance (e.g., ICH, FDA, EMA) before submission

• Lead the preparation and submission of all sections of all regulatory filings to regulatory authorities, including but not limited to IND, ODD, Fast Track CTA, and BLA applications and amendments or supplements, either independently or with limited oversight.

• Prepare meeting requests, coordinating briefing documents and draft responses to questions and requests for information from regulatory authorities.
• Plan and execute regulatory activities that enable a smooth transition from Phase 1 to Phase 2/Pivotal, including protocol amendments, updated CMC information, and global regulatory alignment.
• Collaborate closely with CMC and quality teams to ensure that manufacturing process changes, comparability data, and analytical method validations are accurately reflected in regulatory filings.

• Ensure adherence to current regulations associated with regulatory activities.
• Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise the team accordingly.
• Keep current on FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines as needed to support global programs.

Preferred Experience & Abilities:

• Experience in global submissions and regulatory strategy for Phase 1, Phase 2 and Registrational trials is a plus.
• Familiarity with the interpretation and application of relevant FDA guidelines pertaining to CMC, nonclinical and clinical matters in drug development
• Experience in preparation and submission of IND/CTA/NDA/MAA submissions with regulatory agencies, and ability to contribute to the submission of global regulatory applications
• Hands-on experience supporting global clinical trials, including coordinating multi-region submissions and ensuring compliance with international requirements.
• Track record of regulatory leadership in advancing assets from Phase 1 into Phase 2, including management of associated CMC, clinical, and safety updates.
• Experience engaging with regulatory agencies at different stages and track record advancing compounds into and through the clinic.
• Demonstrated ability to handle multiple competing priorities, prioritize multiple tasks, and utilizing resources effectively
• Specialized knowledge of global and regional regulatory affairs frameworks and guidelines
• Previous experience with Cell or Gene Therapy products

Qualification Requirements:

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred
• 6+ years in Regulatory affairs within pharmaceutical and/or biotechnology industry;
• Early-stage Oncology experience is required.
• Early-stage gene-engineered cell therapy experience is required.
• Experience with CMC regulatory strategy and the preparation of high-quality CMC documentation for submissions (i.e., IND, CTA, BLA, etc.) is required