The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Biologics, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
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.
Essential Dutiesand 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
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
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
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
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%
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.
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About Precision BioSciences
Precision BioSciences, Inc. is dedicated to improving life by developing advanced tools to edit DNA with a uniquely specific approach. Our proprietary method relies on a single small enzyme, ARC Nuclease, which combines cutting with sequence recognition and can be redesigned to find and edit new target sites across the genome. This simple, powerful gene editing solution allows us to create products that solve – not just treat, but solve – significant problems in oncology, genetic disease, agriculture, and beyond. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented, committed people who are excited to be a part of the medical and scientific breakthroughs enabled by Precision’s next generation gene editing technology. For additional information, please visit www. precisionbiosciences.com