VP, Regulatory Science - Innovative Gene Therapies

Location
Boston, MA
Posted
Jun 22, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Reporting To: Chief Regulatory Officer

Location: Boston, MA

Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity to join a rapidly growing, international company focused on transforming the lives of patients through innovative gene therapies. We are at a phase of our development where a Regulatory Affairs professional can have a real impact on the work and foundations that are being created. The person in this role will be a key asset in the filing for exciting ex-vivo Gene Therapy Products. 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 VP of Regulatory Sciences will:

  • Act as the regulatory lead on specific programs and represent the regulatory function on related cross-functional program teams
  • Participate in definition and implement regulatory strategy for path to approval
  • 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
  • Be the primary liaison with regulatory authorities for the specific programs he/she is leading
  • Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities
  • Coordinate and prepare responses to questions, requests for information from regulatory authorities
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
  • Train and mentor other regulatory affairs personnel
  • Other activities as may be assigned

REQUIREMENTS

JOB REQUIREMENTS:

Candidate must possess:

  • Extensive experience in industry‑related Regulatory Affairs
  • Knowledge and understanding of EMA and FDA regulations and guidelines is a must
  • Previous experience in the preparation and submission of regulatory filings, in addition to regulatory submission project management
  • Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. Scientific Advices with EMA, EOP2 meeting with FDA, pre-MAA or pre-BLA, 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; ability to work with remove team

EDUCATION & SKILL REQUIREMENTS:

  • PharmD or PhD in a scientific discipline preferred
  • 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
  • Regulatory Affairs certification is a plus

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.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify

Notice to RECRUITERS: All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.