Manager, 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 Regulatory Affairs team.

 

Job Position
Manager, Regulatory Affairs

Reports to
Director, Regulatory Affairs

Job Description

This position will be responsible for the following areas:

Regulatory Support:  Manages the preparation of regulatory applications associated with the company’s clinical trials for a variety of therapeutic areas and submissions to regulatory authorities.

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

Position Responsibilities:

  • Manage the preparation of applications and subsequent regulatory documents, in accordance with agreed timeframes.
  • Provide regulatory support to other departments.
  • Identifies and documents all regulatory project deliverables from each functional area by project for global regulatory submissions.
  • Determine risk assessment and implement regulatory strategies for products in pre and post-approval stages.
  • 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.
  • Helps facilitate product specific regulatory meetings and functional sub-teams by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines etc.
  • Maintain current knowledge of global regulatory environment. Summarize, analyze and communicate regulatory intelligence and the potential impact.
  • Develop and maintain a positive working rapport with the regulatory agencies.
  • Build long term effective relationships and open communication with cross functional teams to provide accurate information and timeframes.
  • Prepare documents based on the Company’s required format.

Requirements

  • Bachelor’s degree, preferably in a science related field.
  • At least 5 years of relevant regulatory experience
  • 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.
  • Demonstrated ability to work in a team environment to develop, implement and deliver on project goals.
  • Strong sense of ownership and accountabilities.
  • Strong knowledge of Regulatory Agency regulations, guidelines, and/or specifications (e.g., Asia, FDA, ICH, etc) preferred
  • Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.