Director, Regulatory Affairs

Lead regulatory activities for filing INDs, CTAs, and maintenance activities for open applications, including DSURs, IND/CTA amendments, and responses to requests for information/queries. Work effectively and collaboratively with internal and external stakeholders to manage clinical regulatory activities, including study start-up, management of CRO counterparts, completion of initial application submissions & amendments, obtain approvals from regulatory authorities, while ensuring global regulatory compliance standards and commitments are met. Strategically partner with senior regulatory management, development teams, and health authorities to maximize potential for each product in development. Provide regulatory guidance, including identifying and assessing regulatory risk. Ensure that regulatory documents are accurate, complete, and verifiable, and confirm compliance with regulatory requirements. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs. Proactively review and interpret health authority feedback, regulatory precedent, guidelines, and policy to drive product strategy and to guide decision making within cross-functional teams. Work collaboratively with regulatory operations team to provide oversight of relevant regulatory submissions and optimize submission processes. Assist with the management of applicable health authority interactions – planning, briefing material development, and meeting preparation leadership. Provide regulatory representation and expertise on cross-functional project teams and sub-teams/study management teams. Regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, statistical analysis plans, investigator’s brochures, and clinical study reports. Review essential documents for regulatory green light for opening new clinical trial sites and sign off on IP shipments. Establish departmental processes, policies, guidelines, and SOPs. Ensure compliance with all applicable domestic and international regulations. Develop team members, set clear goals, delegate effectively, and monitor performance to ensure the team operates efficiently. Conduct regular 1:1s and deliver timely, actionable feedback; write and deliver meaningful performance reviews for all direct reports. Foster open communication and a motivating team environment, inspiring members to do their best work. BS/MS/PhD in a life science with at least 10 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry; PhD degree may offset some experience requirements. Experience with cell therapy/CAR T/gene therapy products preferred. Demonstrated direct experience with Health Authority submissions and strong knowledge of FDA/EMA/MHRA regulations and agency submission and approval processes. Proven experience in applying regulatory knowledge to various clinical activities; strong knowledge of clinical study design, Good Clinical Practice principles, and navigation of clinical development pathways for novel products. Experience in creating the process for management of the preparation of annual reports, DSURs, and Investigator’s Brochures. Strong knowledge of the regulatory requirements for a variety of clinical regulatory documents (protocols, ICFs, CSRs, etc.). In-depth knowledge of various clinical areas (clinical development, clinical operations, safety, etc.) Strong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly. Excellent operational skills including planning, organizing, and the ability to deal effectively with a variety of personnel both internally and outside the company to drive projects to timely completion. Excellent writing, communication, and interpretive skills. High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently. Veeva Vault RIM experience preferred. Pr