Regulatory Intern

4 weeks ago


New Haven, United States Celldex Therapeutics Full time

Overview

The Regulatory Affairs Coordinator will integrate with the RA team and provide general support as needed under the guidance of RA colleagues. This is an exciting opportunity with potential for growth. The internship will be based out of the New Haven, CT office.

Responsibilities

* Manage accessible inventory of history of health authority interactions.
* Provide submission support as needed.
* Support document publishing.
* Track Regulatory Affairs department priorities.

Qualifications

* Ability to manage priorities and shift focus as needed
* Self-motivated and resourceful
* Strong written and verbal communication skills, including sufficient understanding of scientific documents to review for consistency and occasional comment resolution

Education/Experience:

* Associate degree or higher, including coursework in biologic sciences (intern with at least 2 years completed coursework in biologic sciences)
* General understanding of the drug development process and functional areas within a clinical-stage drug development company

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.



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