Director/ Senior Director, Regulatory Affairs (New Jersey)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on cancer treatment through the development of autologous and allogeneic cell therapies for a range of cancers.

Our portfolio of next-generation therapies is derived from two innovative technologies: CD30-Chimeric Antigen Receptors (CD30-CARs) and a specific subset of T cells known as Virus-Specific T Cells (VSTs). We are also developing a novel, allogeneic platform technology that combines the unique properties of CD30-CARs and VSTs. This platform anchors our next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility, expected to be ready in 2021, will substantially enhance in-house production capabilities and ensure that patients can benefit from our cell therapies more rapidly.

Patients are at the heart of what we do. Our mission is to change cancer treatment and give patients a new lease on life. We are looking for team members who have a passion for creating breakthroughs in cancer treatment. We want to work with people who seek to go beyond, and to pioneer new innovations. You can find out more about our company by visiting our website: www.tessatherapeutics.com.

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.