Senior Associate, Regulatory Operations

Location
Boston, MA, US
Posted
Aug 20, 2019
Ref
4C15946F2D
Required Education
Associate Degree
Position Type
Full time
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 Associate, 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.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 Associate, 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

Responsibilities

The Senior Associate, Regulatory Operations will be responsible for:
  • Hands-on formatting, publishing, performing QCs
  • Transmitting and archiving regulatory submissions
  • Managing regulatory documentation and correspondence
  • Contributing to company implementation of new regulatory operations systems
  • Supporting submission project management

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
  • Prior experience within regulatory operations (including document formatting)
  • 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 and manage multiple activities, priorities and deadlines
  • Proficiency with MS Office, Adobe Acrobat and CSC Toolbox.

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

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.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify