Senior Regulatory Specialist

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 Regulatory Affairs team.

 

Job Position
Senior Regulatory Specialist

Reports to
Director, Regulatory Affairs

Job Description

The Senior Regulatory Specialist will be responsible for the following areas:

Project Management : Co-ordination, prioritization and tracking regulatory deliverables and submissions associated with the company’s clinical trials for a variety of therapeutic areas.

Regulatory Support : Preparation of regulatory applications, under guidance of direct manager, associated with the company’s clinical trials for a variety of therapeutic areas and submissions to authorities.

  • Work closely within the Regulatory department to prepare robust regulatory applications to achieve departmental and organizational objectives.
  • Provide regulatory support to other departments.
  • Identifies and documents all regulatory project deliverables from each functional area by project for global regulatory submissions.
  • Ensures product specific regulatory strategies are documented, maintained, updated, kept on schedule and proactively communicated.
  • Helps facilitate product specific regulatory meetings and functional sub-teams by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines etc.
  • Works closely with the regulatory team and project team to identify and mitigate risks to meeting regulatory submission goals, address any delays and escalates when necessary.
  • Maintain current knowledge of global regulatory

Requirements

  • Bachelor’s degree, preferably in a science related field.
  • At least 3 years of experience in the Biopharma industry preferably with experience in regulatory
  • Demonstrated ability to work in a team environment to develop, implement and deliver on project goals.
  • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills
  • Possess a “can do” attitude
  • Operates effectively in a smaller company and works well across teams within a matrixed organization.
  • Good knowledge of Regulatory Agency regulations, guidelines, and/or specifications (e.g., Asia, FDA, ICH, etc) preferred
  • Good understanding of the overall product development process
  • Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.
  • PMP certification is highly desired