Job Postings

 

Date Posted

Company

Position

  8/31/2020 Precision BioSciences Regulatory Affairs Associate

 The Regulatory Affairs Associate supports the Regulatory Affairs team in preparation and maintenance of documentation for use in regulatory registrations and submissions. The Regulatory Affairs Associate works closely with all members of the Regulatory Affairs team and with other internal groups to ensure compliance of submissions and programs with US, EU, and ICH requirements.

 
  8/31/2020 Precision BioSciences Regulatory Lead, CMC

 The CMC Regulatory Lead will be a key member of the Regulatory Affairs team and interface with various Cell and Gene Therapy groups in the company to provide leadership and guidance for a wide range of topics related to CMC regulatory affairs for our cell and gene therapy development programs. The CMC Regulatory Lead will work closely with all members of the Regulatory Affairs team and with individuals involved in CMC Development, CMC Technical Operations, Quality Assurance, and Quality Control at Precision BioSciences to ensure compliance with US, EU, and ICH requirements.

 
  8/31/2020 Istari Oncology Manager/Sr. Manager, Regulatory Affairs

  Join a growing team at a gene therapy start-up focusing on developing innovative products for oncology. The role is focused on regulatory operations and regulatory writing while contributing to overall program strategy for the company.

 
  08/12/2020 Cato SMS Regulatory Submissions Specialist

 We are currently recruiting for a Regulatory Submissions Specialist to join our team in the San Diego, CA or Cary, NC location.   The Regulatory Submissions Specialist performs the preparation, compilation and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices.

 
  07/15/2020 Chiesi USA, Inc. Regulatory Affairs Specialist 1-3,
Labeling & Promotion

  Responsible for managing the labeling control process, including generation of new labeling and changes to existing labeling, and submission of labeling information to regulatory authorities; and for the regulatory review and submission of advertising and promotional materials for all Chiesi USA products. This position is also responsible for providing input to risk management activities.

 
  06/07/2020 Precision Biosciences Regulatory Writer

The Regulatory Writer will be a key member of the Regulatory Affairs team and interface with various Cell and Gene Therapy groups in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators). The Regulatory Writer will work with the Quality and Regulatory groups to ensure compliance with US, EU, and ICH requirements.

This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed.  This position may require travel up to 10%

 
 
 

 

 

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Regulatory Affairs Specialist 1-3, Labeling & Promotion