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Regulatory

Regulatory Documentation Specialist
T-REG-1

At Therion we are driven by our mission to Extend and Improve the Lives of Cancer Patients through Immunotherapy. 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 currently in Phase III clinical trials (a first for the company) and are looking for a strong team member to work with our Regulatory Operations Manager on publication, management and archiving of all regulatory documents and correspondence. You will support and facilitate the development of submission management policies for the U.S. as well as global environments. If you are interested in supporting the regulatory submission process design and implementation, facilitating the management of the Official Regulatory File, and implementing the electronic document management system for Regulatory then this is the position for you.

We are looking for candidates that embrace our core values of Integrity, Innovation, Collaboration, Compassion, Commitment and Excellence. We also ask that you have a Bachelor�s degree and at least 2 years of relevant experience in a in a company that focuses on the development of drugs or biologics. Experience with regulatory submissions, processes, and basic understanding of US drug and biologics guidelines and regulations as well as international experience and extensive knowledge of electronic publishing is needed. We are also looking for someone who has experience supporting both development projects and marketed products and has the ability to work independently and within a team setting.

For full immediate consideration, interested, qualified candidates are encouraged to email their resume (attached Word document please) and cover letter to:

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

Therion is an equal opportunity employer.

For more information or to apply please contact: [email protected]

 

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