Poseida is seeking a 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
Apply at: https://recruiting.paylocity.com/recruiting/jobs/Apply/428414/Poseida-Therapeutics-Inc/Director-Regulatory-Affairs-CMC