Senior Director, Regulatory Affairs

Company Background

Tessa Therapeutics is a leading biotechnology company specializing in the research, clinical development, and commercialization of cancer immunotherapy treatments. We are a global leader in employing Virus-Specific T cells (VST) to treat cancer. We are currently conducting the world’s first US FDA-registered Phase III T cell therapy trial in NPC, or any cancer indication. We have multiple recruitment sites in the following countries: Singapore, Malaysia, Taiwan, Thailand, and the US. In addition, we have a robust pipeline of both pre-clinical and clinical treatments, targeting multiple cancer indications.

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 Regulatory Affairs team.

 

Job Position
Senior Director, Regulatory Affairs

Reports to
Chief Operating Officer

Job Description

  • Develops and implement regulatory strategies aimed at achieving marketing approvals and appropriate product labelling in the US. Ensure cross functional alignment on regulatory plans and strategies.
  • Responsible for the timely production and submission of regulatory documentation, including investigational new drug and marketing applications (IND, BLA etc) in compliance with US FDA requirements.
  • Ensure compliance with US FDA/ICH regulations and guidelines related to pre-clinical and clinical, regulatory submissions, product launch, labelling and promotional activities.
  • Serve as primary liaison with the US FDA, including overseeing the writing of pre-meeting briefing materials, leading the preparation for meetings with regulatory agencies and ensuring appropriate follow-up
  • Works closely with development teams, by providing guidance and technical input
  • Provides regulatory support to the business development activities to review potential licensing candidates

Requirements

  • Bachelor’s degree in scientific or life sciences discipline or related required, Advanced degree in scientific or life sciences discipline or related (e.g., PharmD, PhD, MD) strongly preferred.
  • Minimum of 15 years of progressive leadership in regulatory affairs in the biotech/pharmaceutical industry is required.
  • Prior working experience at US FDA is preferred
  • Experience in successfully leading submission teams for US FDA Biologics License Application (BLA) and clinical trial applications (CTA) to clearance is required
  • Demonstrated track record for successful interactions with US FDA
  • Experience and/or knowledge of biologics and cell therapies is required.
  • Expert knowledge of US FDA and EMEA and other regulatory guidelines.
  • Candidate must be able to demonstrate strong relationship management, project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).