At Therion we are driven by our mission to Extend and Improve the Lives of Cancer Patients. If you are interested in a fast-changing, dynamic environment in a biotechnology company that is pioneering novel immune therapies for cancer, then Therion is the right company for you.

We are looking for a Director, Regulatory Affairs who will manage the activities supporting registration of Therion�s late stage product candidates. We are currently in Phase III clinical trials (a first for the company) and need an innovative and collaborative leader for the development of the BLA for our lead product, PANVAC�-VF. You will lead the product registration team and provide guidance to all departments involved in the submission process; interact with CBER to determine requirements for clinical, preclinical, and CMC submission content, resolve submission-related issues, and expedite product approval; and oversee the preparation of electronic submissions in compliance with regulatory requirements. In addition, you will manage RA department staff in the preparation of regulatory filings, including budget preparation, training, performance management, and development.

We are looking for candidates that embrace our core values of Integrity, Innovation, Collaboration, Compassion, Commitment and Excellence. Also we would like you to have at least ten years of experience in the biotechnology/pharmaceutical industry, including management experience, with a focus on product development and registration, and an advanced degree, preferably in a related scientific discipline.

We are looking to hire a strong candidate with a thorough understanding of, and proven experience in, the BLA/CTD submission process; experience in electronic submissions; knowledge of the drug development process and laws and regulations affecting the biotechnology/pharmaceutical industry; as well as knowledge of EU and other international regulatory requirements.

For full immediate consideration, interested, qualified candidates are encouraged to email their resume and cover letter to:

[email protected]
Therion Biologics Corporation
Human Resources
76 Rogers Street
Cambridge, MA 02142
Fax: (617) 475-7249

For more information on Therion please see our website at www.therionbio.com

Therion is an equal opportunity employer.