Senior Manager Regulatory Science

Boston, MA, United States
May 28, 2021
Required Education
Bachelors Degree
Position Type
Full time
Senior Manager Regulatory Science

Location: Boston, US

Reporting to: Director, Regulatory

Job summary

Orchard Therapeutics is a leading global, fully integrated, commercial-stage biotech dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.

Partnering with world-leading research institutions in gene therapy, Orchard's portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first autologous ex vivo gene therapy approved by the EMA in 2016, 3 programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), 2 other clinical programs in X-CGD (X-linked chronic granulomatous disease) and betathalassemia, as well as an extensive preclinical pipeline

Key Elements and Responsibilities
  • Submission and document management
  • Managing regulatory documentation and correspondence to ensure required traceability and documents repository
  • Regulatory submission project management
  • Critically review regulatory documents in addition to performing quality control review for accuracy, completeness, and conformance to appropriate regulations, guidelines, and SOPs
  • Assist, support, and contribute to regulatory science activities
  • Assist in the preparation, compilation, and organization of regulatory submissions (e.g. INDs, BLAs, MAAs, annual reports, IND amendments, BLA supplements, etc.) and ensure timely submission of above in accordance with title 21 CFR and FDA, EU and ICH guidelines.
  • Participate in cross-functional team meetings, as required, in collaboration with, and to assist, the global regulatory lead
  • Conduct research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy

  • Requirements

    Required knowledge

    The regulatory group is looking to hire an individual that has a proactive attitude and can work autonomously. Pro-activeness and autonomy are essential in this group due to the size of the team and the variety of work that the team manages on a global level.
  • The ideal candidate would have the following academic and personal attributes:
  • At least 2 years of pharmaceutical industry experience - relevant academic experience may be considered on a case-by-case basis
  • Knowledge of regulatory submissions format and structure (eCTD)
  • Effective organizational administrative and planning skills
  • Project management experience

  • Skills & Abilities

  • Analytical approach to work with excellent attention to detail
  • Ability to work across different projects in a fast-paced global environment and manage multiple activities, priorities and deadlines
  • Proficiency with MS Office and Adobe Acrobat

  • Education
  • . Degree in molecular biology, chemistry, biochemistry, or related scientific field