Senior Director/ Director, Regulatory Affairs
Poseida Therapeutics, Inc. is seeking an outstanding Director or Senior Director of Regulatory Affairs who will be responsible for the development and execution of innovative regulatory strategy for gene and CAR T cell therapy projects. The role will be responsible for the oversight, development, and submission of all regulatory filings and dossiers including INDs, CTAs, and original marketing applications for our gene and cell therapy products. The Director will facilitate cross-functional communication to effectively complete regulatory projects and submissions in a timely manner. This position will report to the Vice President of Regulatory Affairs.
Primarily, the role will:
- Develop and implement innovative regulatory strategy and submission plans for multiple CAR-T and cell therapy products within the oncology field.
- Lead regulatory project team activities and timelines including the planning, preparation, and completion of submissions processes.
- Coordinate the preparation of INDs, CTAs, IMPDs, Technical Files (e.g. DMFs) and other International Registrations. Manage maintenance of existing application throughout their life cycle.
- Prepare responses to FDA letters, supplements, and amendments; participates in FDA inspections and presentations as required.
- Provide oversight and direction to regulatory consultants/vendors to ensure completion of compliant and complete deliverables.
- Write department SOPs and implement training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulations.
- Participate in the preparation of the department’s budget and ensure the department operates within capital and budget guidelines.
- Maintain oversight and knowledge of the therapeutic areas, pharmacovigilance, and product labeling activities through regulatory intelligence, KOL interface, etc; Interpret and impart this knowledge to stakeholders.
- Perform all other related duties as directed by management including the development of guidance for internal staff.
Required Experience and Skills:
- Minimum of a bachelor’s degree in Life science or other related field. Advanced degree in molecular biology, biology or related pharmaceutical field, preferred.
- Minimum of 10 years of relevant biopharmaceutical industry experience, with at least 5 years’ experience in US based Regulatory Affairs submissions, preferably for biologics and/or gene-cell therapy.
- Experience with ex-US submissions and regulatory authorities and/or BLA or MAA filings preferred, but not absolutely required.
- Regulatory experience and knowledge in multiple phases of drug development across various therapeutic areas, with expertise in gene-cell therapy and Hematology/Oncology diseases preferred.
- Strong knowledge of current Good Manufacturing Practices (GMP), cell therapy/ drug development regulations and guidelines including ICH, FDA and EMA guidelines.
- Experience in post-approval dossier life cycle management and direct regulatory interactions desirable.
- Functional knowledge of regulatory management software and eTMF design and maintenance.
- Strong expertise and knowledge of the eCTD structure and submission data standards (CDISC) is required.
- Proficiency in data interpretation and regulatory writing, including the ability to execute and follow-through to completion and documentation.
- Demonstrated ability to effectively lead, coach and mentor colleagues
- Excellent interpersonal communication and analytical skills and ability to communicate effectively across Regulatory Affairs and across the different functions
- Independently motivated and solution oriented
Poseida Therapeutics is translating best-in-class gene engineering technologies into lifesaving cell therapies. The company is developing CAR T-cell immunotherapies for multiple myeloma, prostate and other cancer types, as well as gene therapies for orphan diseases. P-BCMA-101 is Poseida’s lead CAR-T therapy currently in Phase 1 clinical development for the treatment of multiple myeloma. Poseida has assembled a suite of industry-leading gene engineering technologies, including the piggyBac™ DNA Modification System, TAL-CLOVER™ and Cas-CLOVER™ site-specific nucleases, and Footprint-Free™ Gene Editing (FFGE). For more information, visit www.poseida.com.