Manager, Regulatory Operations (12 month Fixed Term Contract)

Location
London, United Kingdom
Posted
Sep 10, 2020
Ref
33F9303434
Required Education
Bachelors Degree
Position Type
Full time
Manager, Regulatory Operations

Location: Remote/London, UK

Reporting to: Director, Regulatory Operations

Contract Type: 12 Month Maternity Cover

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:
  • Plan, manage, track and file all submission types that are required at all stages for all products.
  • Manage the Orchard publishing vendor(s).
  • Support submission management activities.

Responsibilities

The Manager, Regulatory Operations will be responsible for:
  • Publishing management i.e. hands-on formatting, publishing, performing QCs, and transmitting and archiving the regulatory submissions.
  • Vendor management i.e. ensuring that the publishing vendor has all the required information and data they need to accurately deliver all submissions on time.
  • 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


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 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 focused on the preparation of regulatory submissions (formatting, publishing, archiving)
  • 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
  • Proven project/submission management experience, as well as vendor management (or experience as a publishing consultant).

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.

For further information on this role do not hesitate to email HR@orchard-tx.com

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.