Description

Position Summary

The Associate 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.

Responsibilities

These may include but are not limited to:

• Represent the regulatory function on cross-functional development teams
• Develop and implement regulatory product strategies
• 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
• Other duties as assigned

Requirements

Requirements, Knowledge, Skills and Abilities

• Bachelor's degree required, with an advanced degree in science preferred with a 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 preferable; experience in cell and gene therapy a very strong asset
• Knowledge and understanding of global regulations and guidelines
• Ability to perform in a fast-paced, dynamic environment.
• 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

**If currently residing in the state of California we can accommodate you working remotely.