Director/ Senior Director, Regulatory Affairs (New Jersey)

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.

We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

 

Job Position
Director/Senior Director, Regulatory Affairs

Reports To
VP Global Regulatory Affairs

Responsibilities

  • Defines appropriate regulatory strategies to support successful global clinical development plans with focus in the US
  • Provides regulatory support to inter-departmental project teams.
  • Works with global regulatory team members to agree contents for timely submissions to Health Authorities.
  • Responsible for coordinating the preparation and regulatory review of documents for regulatory submissions from all areas of the company.
  • Ensures that data provided are presented clearly and succinctly to optimize the regulatory review and approval process.
  • Directs the activities of and interacts with other Tessa departments in the preparation of initial INDs, CTAs, and regulatory dossiers for marketing applications.
  • Works with Regulatory Operations group to ensure preparation of dossiers containing preclinical, clinical, and technical data in the required eCTD format for submission to obtain regulatory approvals.
  • Liaise with FDA and other health authorities as needed (e.g. submissions, telephone contacts, teleconferences, meetings).
  • Coordinates the preparation of responses to questions and inquiries from Health Authorities.  Prepares and submits IND amendments, safety reports and DSUR in accordance with regulatory submission schedules and regulations.
  • Keeps employees informed of relevant regulatory guidance documents, regulations and information.
  • Other responsibilities, as required.

Requirements

  • Bachelors or advanced degree (Ph.D. or Pharm.D.) in scientific/life-sciences or related field.
  • Director requires a minimum of 8 years experience in regulatory affairs.  Senior Director requires a minimum of 10 years experience in regulatory affairs.
  • Oncology and biologic/cell therapy experience is highly preferred.
  • Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with FDA.