Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.
Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.
Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.
(Senior) Director, Regulatory Affairs
- Defines appropriate regulatory strategies to support successful global clinical development plans with primary focus in the US and also in Europe.
- Provides regulatory support to inter-departmental project teams.
- Works with global regulatory team members to develop contents for timely submissions to Health Authorities.
- Responsible for coordinating the preparation and regulatory review of documents for regulatory submissions from all areas of the company.
- Ensures that data provided are presented clearly and succinctly to optimize the regulatory review and approval process.
- Directs the activities of and interacts with other Tessa departments in the preparation of initial INDs, CTAs, and regulatory dossiers for marketing applications.
- Works with Regulatory Operations to ensure preparation of dossiers containing preclinical, clinical, and technical data in the required eCTD format for submission to obtain regulatory approvals.
- Liaise with FDA and other health authorities as needed (e.g. submissions, telephone contacts, teleconferences, meetings).
- Coordinates the preparation of responses to questions and inquiries from Health Authorities.
- Prepares and/or submits IND amendments, safety reports and DSUR in accordance with submission schedules and regulations.
- Keeps employees informed of relevant regulatory guidance documents, regulations and information.
- Bachelors or Advanced degree (Ph.D. or Pharm.D.) in scientific/life-sciences or related field.
- Director requires a minimum of 8 years experience in regulatory affairs. Senior Director requires a minimum of 10 years experience in regulatory affairs.
- Oncology and biologic/cell therapy experience is highly preferred.
- Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with FDA.
- Occasional travel to HQ in Singapore
- Flexibility to adapt to Singapore and US time zone for cross departments’ meetings