At LogicBio, our mission is to develop medicines to durably treat rare diseases in patients with significant unmet medical needs using, GeneRide™, our proprietary technology platform. GeneRide™ enables the site-specific integration of a therapeutic transgene in a nuclease-free and promoterless approach by relying on the native process of homologous recombination to drive lifelong expression. We are committed to developing medicines that will transform the lives of pediatric patients and their families.
LogicBio is seeking a highly motivated strategic leader to oversee all regulatory aspects of preclinical, CMC, and clinical drug development. This includes the development and implementation of a clear and compelling regulatory strategy, highlighting risks and opportunities, and ensuring timely preparation, review and submission of documents to regulatory authorities in compliance with applicable regulatory requirements. This is a highly-visible and collaborative role where you will help shape the trajectory of the company and its strategic imperatives. The ideal candidate for this role is an individual who has significant regulatory experience in rare disease and in multiple geographies, who is excited to take on new challenges in a fast-paced and entrepreneurial start-up environment.
- Lead the development and implementation of effective and progressive regulatory strategies and plans for the development of the company’s portfolio of product candidates
- Effectively communicate options, solutions and risks to key stakeholders including the product development teams, executive management and the board of directors, as appropriate.
- Partner closely with colleagues in Research, Clinical and CMC to translate nonclinical, clinical and CMC regulatory requirements into practical, strategic regulatory strategies and plans.
- Plan, write, and review drug applications and submissions, as well as represent Regulatory Affairs with various internal departments to manage activities and coordinate in the preparation of regulatory submissions
- Represent the regulatory function on cross-functional development teams.
- Ensure effective collaborations with CROs and other external partners
- Responsible for the coordination, preparation and review of regulatory submissions (US and EU/ROW) in support of clinical trials
- Build effective working relationships and drive communications with regulatory authorities (FDA, EMEA, HC, etc.)
- Develop annual regulatory budget
- Keep abreast of key global guidance documents, regulations, or directives. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.
- Manage relationships with and ensure performance of our external Quality Assurance partners
- Build and lead a high performing Regulatory Affairs and Quality Assurance team as the company grows
- At least 10 years working in Regulatory Affairs in the biotech industry
- Rare disease experience very highly preferred.
- Experience in gene therapy is a plus.
- Deep knowledge and understanding of global regulations and guidelines.
- Previous experience in the preparation and submission of regulatory documents.
- Previous experience leading a company to prepare for major health authority interactions (e.g., IND, FDA preNDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.).
- Must be able to collaborate and work with external consultants and partners (CROs) and cross-functional, internal departments such as Clinical, Commercial, Finance, Research & Development, Manufacturing, etc.
- Ability to work in a fast-paced, start-up environment.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.