Job Postings

Date Posted

Company

Position

 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.

 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.

  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.

 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.

  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.

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%