Senior Associate, Regulatory Operations
Reporting to: Sr. Manager Regulatory Science
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.
The Senior Associate, Regulatory Operations will be responsible for:
- Gathering necessary source documentation for regulatory filings and documenting them appropriately
- Assisting the Regulatory Leads in drafting and preparing regulatory submission packages
- Assisting the Regulatory Leads or BLA/MAA Module leads in providing project management support
- Keeping track of the planning / progress of regulatory submissions, elaborate retroplanning and alert for submissions to come
- Assisting with necessary regulatory surveillance as per SOP, collating and communicating regularly regulatory updates to the regulatory team and any other departments when relevant
- Contributing to company systems development, maintaining regulatory document management system
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. Pro-activeness is 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 affairs and good knowledge of regulatory submissions throughout the medicinal product development as well as CTD format
- 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