Director, Regulatory Affairs - Gene Therapy
Fully Remote San Diego, CA Regulatory Affairs
Description

Please note we can support this role as fully remote.   The states we can consider remote based candidates include:   California, Arizona, Nevada, Texas, Florida, New Jersey, Washington, Massachusetts, Maryland, Pennsylvania, Michigan and North Carolina.   Please be advised that regardless of your location we do observe Pacific hours.

  

Your Impact

You will join a tight-knit Regulatory team offering a unique opportunity to positively influence a growing organization to advance our novel and highly innovative therapies. You will help to drive the development of innovative strategies and provide direction to research, clinical, and manufacturing technical teams. If you enjoy working as part of a highly collaborative and fun team, enjoy creative problem-solving, and like facing new challenges each day - you will love it here! You will learn and advance in your career as this group is forward-thinking and fully supportive of development. We understand the meaning of a team and are looking for an individual that wants to be a part of something bigger and a driving force in changing the lives of patients.


Position Summary

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 and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
  • 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 12 years relevant experience in biotech or pharmaceutical with at least 8 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 preferred.
  • Knowledge and understanding of global regulations and guidelines
  • Ability to perform in a fast-paced, dynamic environment.
  • Early-stage experience in rare disease drug development is preferred
  • 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

  

Salary Range: $246,836 to $290,159

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc.


Who We Are and What We Do

Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure.  We are passionate about making an impact on patients’ lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single treatment cures for patients in need.  Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics.


At Poseida we put people first. Our team is passionate about improving patients’ lives through innovation. See what our team has to say about our culture:


“My favorite part about Poseida is all the people that I get to work with.  Everyone is so passionate about what we’re doing here and there’s so much camaraderie.   It feels like one big enthusiastic family.”


“My favorite part about working at Poseida is the amazing culture and working environment.  Everybody is friendly, professional, collaborative, and has a remarkable can-do and positive attitude.”


As we advance our compelling pipeline, there are endless opportunities for impact and growth.  We encourage you to apply today!