Associate Director, Regulatory Affairs

Company Background

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created 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
Associate Director, Regulatory Affairs

Reports To
Director, Regulatory Affairs

Responsibilities

  • Contributes to the development and evaluation of regulatory strategies for supporting clinical trials with focus in the Asia Pacific and the EU regions
  • 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.
  • Liaise with 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 amendments, safety reports and annual reports etc. 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.
  • Minimum of 6 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 Asia/EU Regulatory Authorities