Orchard Therapeutics is hiring a

Director, Regulatory Operations

London, United Kingdom

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 Director, 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.

Responsibilities

The Director, Regulatory Operations will be responsible for:

  • Leading the selection and implementation of the company regulatory operations systems (EDMS, RIMS, Publishing system)
  • Managing the regulatory operations resources (internal and external)
  • Developing and implementing submission management best practices 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
  • Setting up state-of-the-art document management practices
  • Hands-on formatting, publishing, performing QCs, and transmitting and archiving the regulatory submissions

Requirements

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 candidate should also be senior enough to lead complex project implementation and coach and develop the Regulatory Operations team.

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 EDMS and/or RIMS)
  • Project/Submission management experience, line management experience.
  • Strong knowledge of regulatory submissions format and structure (pre-MAA/BLA; MAA/BLA; post MAA/BLA)
  • Effective organizational administrative and planning skills
  • Analytical approach to work with excellent attention to detail
  • Ability to work across different projects in a fast-paced environment

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.

Benefits

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