The Director/Senior Director, Regulatory Affairs, under the guidance of the VP, Regulatory Affairs, works within the Operations Team with a focus on leading corporate regulatory strategies as well as executing tactical regulatory functions. Specific job functions include regulatory support of the global development and registration of the company’s products, drafting and submission of regulatory documents, license renewals, periodic updates and registrations to regulatory agencies. This role will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. Externally, the Director/Senior Director, Regulatory Affairs will interface with regulatory agencies, corporate partners, consultants and vendors with regards to development, regulatory and registration strategies.
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.
Serves as Regulatory Affairs subject matter expert and program team member for the development and implementation of regulatory strategy for cell and gene therapy programs, as assigned
Plans, contents, timelines and guides subject matter experts (SMEs) on the preparation of IND and BLA submissions and amendments to FDA with an overall objective to receive approval within the shortest time frames possible
Critically reviews all documents prior to submission to ensure thoroughness and quality
Actively pursues use of expedited approaches to help advance programs through clinical development
Develops strategy for health authority meetings, develops contents, and manages meetings with FDA (e.g. pre-IND, EOPI/II, pre-BLA) and other health authorities to expedite development programs
Interacts with internal and external stakeholders, including FDA and other external regulatory and quality agencies, to collect and share information
Acts as main liaison with health authorities, as assigned, and submits controlled correspondence to FDA/other health authority on specific issues as needed
Coordinates with internal departments and CRO partners for preparation of required clinical documents (e.g. Investigator Brochures, Informed Consent forms)
Supports regulatory team to develop and implement regulatory initiatives from pre-IND through approval/commercialization and post-approval activities
Monitors impact of changing regulations on submission strategies and updates internal stakeholders accordingly
Works with QA on regulatory compliance issues, as needed
Independently applies the appropriate regulatory guidance or guideline documents and regulations to judge the appropriateness of solutions
Identifies and uses appropriate methods to collect the needed information to allow analysis and reach conclusions
Shows good judgment to determine when to escalate problems to his/her supervisor
Ph.D. or Masters Degree (MS/MA) in biological sciences with 15+ years of regulatory affairs experience; advanced therapy experience a plus
Working knowledge and experience with 21 CFR, cGCPs, cGLPs, and cGMPs
Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements
Technical writing proficiency and proofreading abilities
Track record in working successfully on IND/CTA and BLA/MAA applications to and health authority meetings with, the FDA/EMA
Expert knowledge in authoring or assembling and submitting technical files/regulatory dossiers to the regulatory agencies such as the FDA and EMA including eCTD format and eSubmissions
Strong computer skills in order to learn new programs as quickly as possible; experience in MS Word, Excel, Outlook and Adobe Acrobat is a must
Ability to communicate effectively both verbally and in writing
Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure and acting with integrity and credibility to build trust.
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.
Employer will assist with relocation costs.
Internal Number: n/a
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