Manager, Regulatory Operations - London


Full-time

London, England, United Kingdom

Regulatory Affairs

Orchard Therapeutics is a leading global fully integrated commercial and clinical-stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. As part of our on-going growth, we are currently recruiting for a Manager, Regulatory Operations to join the regulatory team in order to help plan, manage, track and file the multiple forthcoming submissions, including BLA and MAA filing.

Requirements

The Manager, Regulatory Operations will be responsible for:

  • Contributing to company regulatory operations systems implementation and development (e.g. publishing system)
  • Hands-on formatting, publishing, performing QCs, and transmitting and archiving the regulatory submissions
  • Submission management i.e. assisting the Regulatory Leads in preparing regulatory submission packages, gathering necessary source documentation for regulatory filings and documenting them appropriately, keeping track of the planning / progress of regulatory submissions, elaborating retro-planning and alerting for submissions to come
  • Managing regulatory operations resources (internal and external)

This is a great opportunity for an individual to build upon their regulatory experience within the rare disease space. The experience that can be gained in this role is truly unique and can create an excellent next step for a successful career in regulatory affairs.

Job Requirements & Education

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:

  • Education to Bachelor’s/advanced degree level in a scientific discipline
  • Strong prior experience within regulatory operations (including on the implementation of a new publishing system)
  • Strong knowledge of regulatory submissions format and structure (pre-MAA/BLA; MAA/BLA; post MAA/BLA)
  • Effective organisational administrative and planning skills
  • Analytical approach to work with excellent attention to detail
  • Ability to work across different projects in a fast paced environment
  • Project/Submission management experience, line management would be a plus.