Poseida is seeking an Associate Director/Director, CMC Regulatory Affairs to provide support for development and future marketed products including driving the development of innovative CMC strategies and providing direction to research, clinical, and manufacturing technical teams. Reporting to the VP, Regulatory Affairs, this individual will be responsible for assuring the CMC regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and high quality.
These may include but are not limited to:
- As a member of the project teams, provide strategic CMC regulatory leadership support for multiple innovative cell and gene therapy programs.
- Provide CMC expertise for global development and registration programs (e.g., INDs, CTAs, NDAs and MAAs)
- Primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for CMC related issues.
- Lead negotiations with regulatory agencies to resolve CMC issues and oversee proactive interactions with regulators globally for initial INDs/CTAs, marketing registration applications, supplements and variations.
- Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Responsible for compilation, review, approval and submission of high-quality CMC related sections of INDs/CTAs, including responses to questions from various regulatory authorities, working in collaboration with SME’s in Research, Process Development, Manufacturing, Quality, Global Supply Chain and other business partners. Maintain responsibility for all CMC Regulatory timelines.
- Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
- Support interactions with regulatory agencies during inspections
- Manage contract staff and vendors as needed to support regulatory activities
- Other duties as assigned
Requirements, Knowledge, Skills and Abilities
- Advanced scientific degree preferred in the sciences, or health related field minimum, with a minimum of 10+ years CMC regulatory experience (an equivalent combination of education and experience may be considered)
- Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of biologics. Cell Therapy experience would be preferred
- Established working knowledge of regulatory guidelines and regulations including Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines (e.g., ICH, FDA and EMA guideline)
- Regulatory experience supporting both development projects and marketed products including support of post-approval dossier life cycle management
- Experience with Orphan Drug Designation, BTD, RMAT, direct interactions supporting health authority GMP inspections desirable is preferred
- Strong knowledge of eCTD elements and structure including CMC-regulatory writing skills
- 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
- Ability to work independently and as part of a team and drive results
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
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.