Director of Regulatory Affairs - Innovative Gene Therapy Start Up

Boston, Massachusetts, United States

Description

Location: Foster City, CA, London, UK or East Coast, US

Reporting to: Chief Regulatory Officer

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created a year ago, it is in an exciting start-up phase where a Regulatory Affairs professional can have a real impact on the work and foundations that are being created. This role will report directly to the Chief Regulatory Officer based in Europe and will be a key asset in the BLA Filing for an exciting ex-vivo Gene Therapy Product. This opportunity is unique due to the size of the team and the ground breaking science.

Responsibilities

Under the guidance of the Chief Regulatory Officer the successful candidate will:

- Participate in definition and implement regulatory strategy

- Represent the regulatory function on cross-functional development teams

- Provide regulatory guidance and strategy including identifying and assessing regulatory risks

- 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)

- Lead 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

- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs

- 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

- Train and mentor other regulatory affairs personnel

As primary objective, upon joining, the successful candidate will act as leader for the BLA preparation of the lead program at Orchard Therapeutics. This will include:

o Implement strategy agreed upon with FDA regarding path to BLA

o Plan, prepare, coordinate inputs from subject matter experts and review BLA before submission to FDA

o Ensure compliance

o Ensure achievement of timelines

Requirements

  • PharmD or PhD in a scientific discipline preferred
  • Extensive experience in industry-related Regulatory Affairs
  • Knowledge and understanding of FDA regulations and guidelines is a must
  • Previous experience in the preparation and submission of a BLA file is a must
  • Previous 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 etc.)
  • Knowledge and understanding of global development and previous experience with other authorities is a plus
  • Knowledge and experience of development of cell or gene based therapy is a plus
  • Ability to work in a cross-functional team environment with experience managing people and project teams
  • Strong attention to detail and the ability to handle multiple tasks
  • Excellent organizational, computer and documentation skills and an ability to prioritize effectively
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment and to interact efficiently with Authorities
  • Benefits

    The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.

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