Senior Manager Regulatory Operations

Orchard Therapeutics Boston , MA 02108

Posted 1 week ago

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 Senior Manager, Regulatory Operations to join the regulatory team in order to help manage and structure the regulatory operations.

This is a great opportunity for an individual to build upon their regulatory operations 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.

Requirements

The Senior Manager, Regulatory Operations will contribute building and be responsible for maintaining a global, lean, state-of-the art Regulatory Operations system and department. This includes:

  • Contributing to select and leading the implementation and maintenance of new company regulatory operations systems (e.g. publishing system, eDMS, SPOR database, regulatory tracking database)
  • Management of Regulatory Operations resources internationally (internal and external)
  • Proactively plan all regulatory operations activities globally; ensure they are conducted on time and with the highest quality level
  • Be the reference person for all technical regulatory operations questions, especially those related to submissions to US FDA (IND, BLA, ).
  • Hands-on formatting, publishing, performing QCs, submitting and archiving the regulatory submissions
  • Developing submission management support to Regulatory Leads 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 the team for submissions to come

Job Requirements & Education

The regulatory group is looking to hire an experienced individual who has a proactive attitude and can lead their colleagues build a top-notch regulatory operations department. Planning and execution capabilities, as well as flexibility 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 Bachelors/advanced degree level in a scientific discipline
  • Strong prior experience within regulatory operations at large i.e. from document creation to publishing and submission and eDMS management
  • Proven experience in the installation of new regulatory operations systems, in particular a new eDMS and a new electronic Publishing system
  • Line management experience
  • Project 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
  • Ability to work with remote teams, with an international mindset

NOTICE TO ALL APPLICANTS: Orchard Therapeutics participates in E-Verify

RECRUITERS

All employment offers and CVs 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.

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