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Manager - Regulatory Affairs

Employer
Precision BioSciences, Inc.
Location
Durham, NC, United States
Start date
Sep 11, 2019

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC

Job Details

The Manager, Regulatory Affairs will be a key member of the Development organization and interface with the Cell and Gene Therapy project teams to manage regulatory aspects of projects related to clinical trials, health authority interactions and product approvals. The Manager, Regulatory Affairs works with medical/technical writing and Quality personnel to ensure compliance of submissions and programs with US, EU, and ICH requirements.

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.
  • Manage the regulatory aspects of projects/products including the preparation and submission of INDs/CTAs, amendments, correspondence and meeting applications to regulatory agencies, including FDA, Health Canada, EMA, local European agencies
  • Represent Regulatory Affairs and offer proactive solutions at product team and clinical project team or other sub-teams meetings as assigned
  • Communicate regulatory information to and work with cross-functional multidisciplinary study teams on preparation of internal documents that are in compliance with regulatory guidance
  • Work with technical and medical writing to manage and submit product prioritization designation requests, e.g. orphan drug, fast track, regenerative medicine, PRIME, etc., in US, Europe and Japan
  • Work with medical writing and clinical operations to manage IND Annual Reports/DSURs and ensure timely safety reporting to regulatory agencies
  • Work with technical and medical writing to manage document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables
  • Work with CMC team to manage preparation of CMC/IMPD documentation and change control reporting per each health authority requirements
  • Maintain archive and tracking of ongoing INDs/CTAs submissions, FDA/Health Authority communication and related issues to resolution
  • Work directly with the electronic publisher to get submissions published and submitted
  • Participate in direction/supervision of vendors involved in providing Precision BioSciences with additional regulatory support
  • Performs other related duties/responsibilities as required or assigned by the supervisor

Qualifications

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

Education/Experience:
  • Degree in Biological Sciences with at least 5-7 years of regulatory experience in the Pharmaceutical industry (preferably Biotech); advanced degree in health sciences preferred or a B.Sc. with 10 years of relevant experience
  • Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics
  • Expert knowledge of eCTD and filing of INDs; experience with BLA filing, preferred
  • Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPD, CTAs, and MAAs and related health authority interactions is preferred
  • Ability to critically analyze, synthesize, and present complex information in well-constructed documents
  • Ability to support multiple projects and to prioritize work independently
  • Confidence to present to management, peers, and scientific or business collaborators
  • Strong written and verbal communication skills

Work Environment
  • This position operates in a professional office environment, and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines
  • Travels when necessary to client sites or professional meetings
  • Typically works at a desk and computer in a climate-controlled office environment
  • Responsible for meeting tight deadlines
  • Participates in lengthy meetings with research groups, clients, and company management

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • The employee must occasionally lift and/or move up to 25 pounds
  • Specific vision abilities required by this position include close vision, distance vision, and depth perception
  • While performing the duties of this position, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel, reach with hands and arms, and talk or hear

Travel Requirements
  • This position may require ~10% travel on a periodic basis


Precision BioSciences mission and vision is to translate the worlds most powerful genome editing technology into greatly needed products throughout the life sciences, by being the conduit through which the greatest genome engineering challenges are solved. Precisions wholly proprietary ARCUS genome editing platform enables the production of highly specific nucleases that can insert, remove, and modify DNA at essentially any location in a complex genome. Through our ARCUS platform, we are developing genome editing-based products to address critical needs in oncology, genetic disease, agriculture, and beyond. For additional information, please visit www.precisionbiosciences.com

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.

Company

Precision BioSciences, Inc. (Nasdaq: DTIL) is a clinical stage gene editing company developing in vivo gene editing and ex vivo allogeneic CAR T therapies with its highly precise and versatile ARCUS genome editing platform. ARCUS uses sequence-specific DNA-cutting enzymes, or nucleases designed for gene knock out, as well as highly sophisticated edits for gene insertion and/or gene repair. Precision’s in vivo gene editing pipeline consists of wholly-owned preclinical candidates for primary hyperoxaluria type 1 (PBGENE-PH1), familial hypercholesteremia (PBGENE-PCSK9) and chronic hepatitis B (PBGENE-HBV). It has also partnered with Lilly to develop candidates for Duchenne muscular dystrophy and two other programs targeting the liver and CNS. Precision’s allogeneic CAR T pipeline consists of multiple investigational candidates in early-stage clinical trials, including its first and second generation CD19 targeting candidates PBCAR0191 and PBCAR19B for relapsed and/or refractory (R/R) non-Hodgkin and B-cell lymphoma patients. Precision has also prioritized development of PBCAR269A, its BCMA targeted candidate in combination with a gamma secretase inhibitor for R/R patients with multiple myeloma. Precision BioSciences and its in-house manufacturing facility for AAV, mRNA, and CAR T cells is based in Durham, North Carolina. For more information about Precision BioSciences please visit www.precisionbiosciences.com

Stock Symbol: DTIL

Stock Exchange: NASDAQ

Company info
Website
Phone
919-314-5512
Location
302 East Pettigrew Street
Durham
North Carolina
27701
US

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