Director/Senior Director, Regulatory Affairs

Location
Durham, NC, United States
Posted
Oct 10, 2019
Ref
1156048
Hotbed
Bio NC
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 companys 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 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.
  • 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

Education/Experience
  • 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.