Biological Products Regulatory Affairs Manager

Boston MA
Bioprocessing
Full-time
Joyn Bio is a joint venture between Bayer and Ginkgo Bioworks dedicated to addressing unmet needs in agriculture by applying synthetic biology approaches to engineer microbes.

Objective

    • The Regulatory Affairs Manager  is a highly collaborative role that coordinates permitting, registration dossier submissions, record-keeping, study protocols and reports for Joyn’s unique portfolio of engineered microbes for agricultural applications.

Responsibilities

    • Develop regulatory strategy for Joyn Bio as part of a cross-functional team, in conjunction with external regulatory consultants.
    • Work with cross-functional program teams and external regulatory consultants to obtain permits (e.g. USDA APHIS PPQ or BRS, EPA TERA) for shipping and application of  live microbial formulations for manufacturing, and greenhouse and field evaluation.
    • Work with cross-functional program teams to assemble data and strain information in support of preparation of dossiers for submission to regulatory agencies.
    • Work closely with the head of bioprocessing and formulation development to establish procedures for regulatory studies in support of the company’s technical and regulatory strategy.
    • Identify outside contractors for regulatory science studies as needed for dossier preparation.

Training/Experience

    • 5+ years of industrial experience with regulatory affairs in crop protection, biological products, or seeds.
    • Working knowledge of  quality management systems  such as GLP and/or ISO and their requirements for regulatory studies.
    • Working experience with regulatory agencies such as USDA, EPA, FDA is a plus.
    • B.S./M.S. in microbiology, chemistry or a related technical discipline

Organizational

    • This position reports into the Head of Bioprocessing and Formulation.
    • This individual will be part of the Boston-based Bioprocessing and Formulation Development  team.
Location
This position will be based at our Boston, Massachusetts site and will require 5-10% travel.