Specialist, CMC 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
Specialist, CMC Regulatory Affairs

Reports To
Vice President, Regulatory CMC

Responsibilities

Change Control

  • Participate change control review board meeting and communicates details of change with the CMC team.
  • Document global reporting categories and track reportable change controls for necessary submissions.

Regulatory Submission Site Support

  • Coordinate planning and review of IND/BLA CMC documentation
  • Coordinate and prepare regulatory CMC submissions in Asia as assigned
  • Coordinate manufacturing deviation regulatory assessment
  • Support site inspections and audits
  • Monitor regulatory commitment

Regulatory intelligence

  • Build Health Authority query and response database
  • Build global CMC requirements for cell and gene therapy

 

Requirements

  • Minimum of bachelor’s degree in Science (e.g. Biology, Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. Minimum 4 years of pharmaceutical industry experience with 2 years in Regulatory CMC for biologics. Experience in cell/ gene therapy is preferred.
  • Demonstrated project management experience and can work in a cross-functional team environment to develop, implement and deliver on project goals.
  • Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.
  • Experience in ICH guidelines and cGMP requirements.
  • Experience in writing CMC document following Common Technical Document format
  • Experience in manufacturing process, product or analytical development for biological products
  • Experience in Health Authority inspection
  • Excellent organizational and project management skills
  • Strong communication (written and verbal) skills