Associate Director, Regulatory Science

Our client, a global gene therapy leader with U.S. headquarters in the Greater Boston area, is focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Title: Associate Director, Regulatory Science Location: Remote (US) Reports to: Executive Director, Regulatory Science (US) Job Summary This role is a unique opportunity to join the Regulatory Science team, which is responsible for the development of global regulatory strategy and execution of regulatory activities for ex-vivo Gene Therapy assets. This position is ideal for someone with a solid US regulatory background who can develop innovative regulatory strategies and apply strong skills in execution, collaboration, problem-solving, and attention to detail to contribute to groundbreaking science. Key Responsibilities Act as US regulatory lead on assigned program(s): Work in close partnership with the Global Regulatory Lead(s) and under the oversight of the Executive Director, Regulatory Science to provide necessary regulatory inputs to the related cross-functional program teamsDevelop the US regulatory strategy, including any innovative procedures to expedite the path to approval, in line with corporate goals, in partnership with the Global Regulatory Lead(s) and the program regulatory team(s)Help identify regulatory risks, develop mitigation strategies, and support proactive agency engagement plansSupport integrated regulatory planning across clinical, nonclinical and chemistry and manufacturingExecute the US regulatory strategy: be the primary liaison with US regulatory authorities for the assigned program(s); plan, prepare, and review submissions to the FDA, including Orphan designation applications (ODD), Investigational New Drug (IND) applications, Fast Track/RMAT designations, and Pediatric study plans; prepare FDA meeting requests, briefing documents, coordinate and prepare cross-functional teams for meetings, and interface with US regulatory authorities; coordinate and prepare responses to questions and requests for information from US regulatory authorities; ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with the defined timelines Actively Participate In Regulatory Compliance And Regulatory Team Development Monitor, analyze, and disseminate intelligence on US regulatory matters that may affect ongoing development programsLead the implementation of new US regulations/guidelines applicable and relevant to development programs in close collaboration with the Global Regulatory Lead(s) and relevant functional leadsContribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activitiesParticipate in internal audits and future health authority inspectionsShare expertise and learning experiences within the regulatory team Required Knowledge/Experience Significant experience in the development and execution of US regulatory strategies for development programs in industry-related US Regulatory AffairsKnowledge and experience of development/registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is a plusVery good knowledge and understanding of US CFR and FDA guidelines is a must — understanding of EMA regulations and guidelines is a plusPrevious experience in using US innovative expedited paths to approval in the frame of global development is a plusTrack record of INDs preparation, management up to FDA clearance and maintenancePrevious experience of leading a team to prepare for and attend major health authority interactions (e.g., pre-IND meeting, EOP1, EOP2 meetings, etc.)Experience in regulatory submission project managementPrevious experience in the preparation and submission of a BLA is a plus Education / Key Competencies PharmD or PhD in a scientific disciplineRegulatory Affairs certification is a plusStrong attention to detail, translating into the ability to produce high-quality regulatory documentsAbility to establish and maintain a positive, strong and efficient collaborative working relationship within the Regulatory team and with other functions and stakeholdersAbility to handle multiple tasks in parallel in a fast-paced environment; ability to plan, prioritize and respond effectively to program/activities changesAbility to develop partnerships that support a strong cross-functional and inclusive team environmentAbility to work in autonomy on allocated program(s)Excellent organizational, computer and documentation skillsSolution-oriented approach to problem-solving including assessing variables, evaluating fundamental issues, anticipating business impact and providing directionGeneral interest in a broad range of Regulatory activitiesStrong interpersonal skills including verbal and written communication Salary Range The anticipated salary for this position is $190,000 - $240,000, plus a comprehensive benefits and incentive package. Actual salary may vary based on experience, qualifications, and location. Our client is an equal opportunity employer.