Regulatory Affairs Associate III

Location
Durham, NC, United States
Posted
Aug 01, 2021
Ref
1663173
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
The Regulatory Affairs Associate III 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 Affairs Associate III will work with the Quality and Regulatory groups to ensure compliance 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.
  • Generates and reviews documentation (such as protocols, investigator brochures, informed consents) as well as clinical data review packages, CTD module summaries, and study reports.
  • Supports clinical trial readiness by working with clinical operations and CROs as needed for generation/review/editing of clinical study documentation including IRB/IBC communications/responses, study manuals, etc.
  • Prepares orphan drug and other specialty applications for cell and gene therapy programs
  • Maintains consistent high quality and efficiency in the generation of documentation to support regulatory filings
  • Works with technical teams to convert study data and results into reports in support of regulatory submissions
  • Provides training and mentoring to subject matter experts on technical writing skills and best practices
  • Reviews and edits documents including those authored by others both internally and externally
  • Is a collaborative team player participating in both internal and external project team meetings as needed, and offers proactive solutions and advice to team members
  • Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones, and document deliverables
  • Ensures documents are finalized for submission including publishing readiness, quality checks, and finalization of all supporting literature
  • Trains on Precision BioSciences document management systems, authors and/or reviews departmental (clinical and regulatory) SOPs as needed
  • Performs other activities as assigned


Qualifications

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

Required:
  • Degree in Biological Sciences; BS or MS with 5+ years experience or Ph.D. and 2+ years experience in a technical writing capacity, or equivalent combination of education and experience
  • Confidence to present to management, peers, and scientific or business collaborators
  • Strong written and verbal communication skills
  • Familiarity with the key requirements for clinical documentation for regulatory submissions in ICH regions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics
  • Experience in reviewing and writing regulatory submission documents for US regulatory filings such as INDs, NDAs, and BLAs
  • Ability to critically analyze, synthesize, and present complex information in well-constructed documents
  • Working knowledge of drug/biologics development, clinical research, study design principles the US regulatory environment for cell and/or gene therapy product development, and general medical terminology
  • Ability to support multiple projects and to prioritize work independently
  • Ability to comply with company and/or industry style guides and templates
  • Ability to guide and train others in the writing of technical documentation
  • Fluent written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy
  • Advanced MS Skills in Word, Excel, and Adobe Pro


Preferred:
  • Working knowledge of basic biostatistics principles, pharmacovigilance, and rare disease product development in general
  • Some experience authoring and maintaining CMC documentation for IND-stage products
  • Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPDs, CTAs, and MAAs
  • Familiarity with electronic publishing and submission requirements
  • Experience working in a Regulatory Information Management System


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.


Travel Requirements
  • This position may require travel up to 10%


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 isnt just a statement supporting the products that were developing its 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.