The Regulatory Affairs Associate II supports the Regulatory Affairs team in preparation and maintenance of documentation for use in regulatory registrations and submissions. The Regulatory Affairs Associate II 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.
**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.
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
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
• Bachelor’s 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 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
• Experience with electronic publishing
• Ability to support multiple projects and to prioritize work independently
• Strong written and verbal communication, negotiation, and interpersonal skills
• No travel is expected for this position
• 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, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com
Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide 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.