Senior Associate Regulatory Science

Recruiter
Orchard Therapeutics
Location
Boston, Massachusetts
Posted
Oct 09, 2019
Closes
Oct 13, 2019
Ref
15620d65ffd0
Sector
Law
Organization Type
Corporate
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 Science to join the regulatory team in order to
  • Submission and document management
  • Assist and support regulatory science activities.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 Science to join the regulatory team in order toi) Submission and document management ii) Assist and support regulatory science activities.

Requirements

Responsibilities
  • Submission and document management
  • Assist and support regulatory science activities
  • Managing regulatory documentation and correspondence to ensure required traceability and documents repository
  • Regulatory submission project management
  • Critically review regulatory documents in addition to performing quality control review for accuracy, completeness, and conformance to appropriate regulations, guidelines, and SOPs
  • Assist in the preparation, compilation, and organization of regulatory submissions (e.g. INDs, BLAs, MAAs, annual reports, IND amendments, BLA supplements, etc.) and ensure timely submission of above in accordance with title 21 CFR and FDA, EU and ICH guidelines.
  • Participate in cross-functional team meetings, as required, in collaboration with, and to assist, the global regulatory lead
  • Conduct research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy

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:
  • Ph.D.in molecular biology, chemistry, biochemistry, or related scientific field
  • 2 years of pharmaceutical industry experience - relevant academic experience may be considered on a case-by-case basis
  • Knowledge of regulatory submissions format and structure (eCTD)
  • Effective organizational administrative and planning skills
  • Project management experience
  • Analytical approach to work with excellent attention to detail
  • Ability to work across different projects in a fast-paced global environment and manage multiple activities, priorities and deadlines
  • Proficiency with MS Office and Adobe Acrobat

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