The Director, Regulatory Affairs is a product-facing role that provides regulatory leadership in support of the development programs at Poseida. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This person represents the regulatory function on multi-disciplinary teams and must integrate company goals into the objectives and activities of the Regulatory Affairs Department. The successful candidate will serve as a resource to team members for the regulatory requirements to conduct drug development activities for cell and gene therapy products.
These may include but are not limited to:
- Develop and implement regulatory product strategies
- Represent the regulatory function on cross-functional development teams
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies
- Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) throughout the lifecycle of assigned projects
- Lead and oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
- Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
- Serve as the Regulatory Lead for assigned Regulatory Project Teams in the development of global regulatory strategies
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
- Provide interpretation of and advice regarding regulations, directives, and guidance
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
- Coordinate and prepare responses to requests for information from regulatory authorities
- Train, manage, and mentor other regulatory affairs personnel
- Other duties as assigned
Requirements, Knowledge, Skills and Abilities
- Bachelor’s degree required, with an advanced degree in science preferred
- Minimum of 10 years relevant experience in biotech or pharmaceutical with at least 5 years as the regulatory affairs representative on project development teams (an equivalent combination of education and experience may be considered)
- A strong scientific and technical background in molecular biology and biologics is essential and required; experience in cell and gene therapy a very strong asset
- Knowledge and understanding of global regulations and guidelines
- Early-stage and late-stage experience in oncology drug development; familiarity with RMAT, PRIME is desired
- Previous experience with BLA/NDA filings a must
- Experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU scientific advice, etc.)
- Ability to work effectively in a collaborative cross-functional team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem-solving ability
- Excellent organizational skills, with a high attention to detail and an ability to embrace change and multi-task in an extremely fast-paced environment
- Ability to serve as primary point of contact for regulatory agencies
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to firstname.lastname@example.org.