Regulatory Affairs Intern - Uxbridge, United Kingdom - Regeneron Pharmaceuticals Inc.

Regeneron Pharmaceuticals Inc.
Regeneron Pharmaceuticals Inc.
Verified Company
Uxbridge, United Kingdom

4 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

You will be part of a regional team dedicated to supporting the Regulatory Affairs function in the context of drug development particularly around procedures in place for the conduct of clinical studies through to the approval of a new drug.

You will work both internally with colleagues and stakeholders in Regeneron.


Responsibilities include:

Work with clinical study teams to ensure appropriate regulatory support from CROs and other partners.

Serve as additional resource to regulatory teams to track changes in EU and UK legislation and guidelines thereby ensuring Regeneron remains compliant with same.

Ensure agency correspondence is filed and archived in accordance with Regeneron's processes.
Support agency interactions such as scientific advice, national meetings etc.

Support members of the regulatory team including Regulatory Submission Project Management (RSPM) with any emerging regulatory projects, workstreams, processes or work instructions.

Present to European Regulatory Team a regulatory topic of interest (to be agreed with Line Manager)

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

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