Regulatory Affairs Associate

Location
Durham, NC, United States
Posted
Aug 29, 2020
Ref
1380231
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
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.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
  • Prepare routine submission documents including cover letters and forms; as appropriate, lead the development of technical documents, such as IND Annual Reports and Orphan Drug Annual Reports
  • Coordinate with cross-functional team members to support regulatory document authoring and review
  • Perform document review and processing activities for documents intended for regulatory submissions, including general formatting, grammatical review, template and style guide adherence and version control.
  • Work directly with the electronic publisher to oversee submission publication and delivery to regulatory agencies; ensure final submissions are electronically archived
  • Manage the regulatory email inbox, triaging messages or escalating to other team members as appropriate
  • Maintain regulatory information tracking systems for INDs/CTAs submissions, communications with FDA/Health Authorities, and regulatory agency commitments
  • Perform other related duties/responsibilities as required or assigned by the supervisor


Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:
  • Bachelors Degree in Biological Sciences; advanced degree preferred, with at least 2 years of regulatory experience in the Pharmaceutical industry (preferably Biotech), or equivalent combination of education and experience
  • Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and GxP
  • Strong understanding of IND filing requirements
  • Experience with electronic publishing

Preferred:
  • Experience with BLA filing
  • Experience reviewing and editing documents for regulatory submissions such as INDs, IMPDs, CTAs, BLAs, and MAAs, as well as related health authority interactions
  • Experience using a Regulatory Information Management System
  • Ability to support multiple projects and to prioritize work independently
  • Strong written and verbal communication, negotiation, and interpersonal skills


Travel Requirements
  • No travel is expected for this position


Location
  • 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.


Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.