Director, Regulatory Affairs

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, Regulatory Affairs

Reports To
Global Head, Regulatory Affairs

Responsibilities

  • Responsible to develop US regulatory filing strategy for the assigned genetically modified cell-based cancer immunotherapy products; compile and submit regulatory documents to the US FDA according to current regulatory requirements and applicable timelines;
  • Serve as a liaison with the US FDA and ensure optimal early interactions with the Agency. Manage and oversee responses to regulatory authorities’ questions with strict deadlines and identification and mitigation of regulatory risk/gaps;
  • Act as US Regulatory Program Lead for one or more of the products of the Tessa Therapeutics’ pipeline and responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials and product registrations; Identify and assess regulatory risks for assigned projects / programs;
  • Involvement in Regulatory documents and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions;
  • Oversee submission tracking information and inform program / project teams and senior management on real time status of business-critical submission;
  • Coordinating the generation, edit, review and submission of INDs, DSURs, safety reporting, BLAs etc;
  • Stay up to date with US regulatory requirements relevant for company pipeline/products, and interpreting and distributing regulatory intelligence to the internal teams;
  • Develop detailed regulatory project plans and timelines and support regulatory activities relating to specific portfolio of products/projects;
  • Participate as an active team member and provide regulatory support to cross-functional program and project teams as required on all aspects of Regulatory, CMC, non-clinical and clinical aspects during all stages of drug development;
  • Contribute to the Target Product Profile and Quality Target Product Profile;
  • Prepare and deliver effective presentations for external and internal audiences;
  • Effectively communicate with internal stakeholders to lead and ensure regulatory strategy is understood, aligned with Program and Project milestones and implemented by the cross functional teams;
  • Drives the interpretation and implementation of new regulatory agency guidelines and legislation relevant to regulatory submissions;
  • Contribute to preparation and maintenance of Regulatory SOPs, working procedures and checklists related to templates, electronic submission processes and archiving.

Requirements

  • Master in Pharmaceutical Sciences, Life Sciences or equivalent with at least 10 years in biopharmaceutical / pharmaceutical / biotech industry, in a similar role in Regulatory Affairs; or a PhD in Pharmaceutical Sciences, Life Sciences or equivalent with at least 7 years in biopharmaceutical/ pharmaceutical / biotech industry, in a similar role in Regulatory Affairs;
  • US Regulatory expertise in Oncology, Immuno-oncology, Biologics Development, or Cell Therapy, Gene Therapy highly desirable.
  • Experience in coordination, preparation and conduction of regulatory agency meetings with the US FDA and related materials is a must
  • Ability to think strategically and to proactively identify issues in various aspects of the drug development process;
  • Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects;
  • Demonstrated effective cross-cultural awareness and capabilities;
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research);
  • Experience in eCTD-compliant regulatory submissions;
  • Experience in interacting with FDA in all phases of clinical development stages
  • Experience in leading and managing complex filing projects within specific timeframe