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Last Name*

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First Name*

Last Name*

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Job type: Permanent

Discipline: Project Manager, Labelling & Artwork, RA Intelligence

Location: United States

Proclinical is currently recruiting for a Regulatory Project Manager with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

Chron files, filing and updates
Support Annual reports (IND and NDAs; N=70)
Support for preparation, follow-up for PADERS, PSURs
Minor labeling updates, PSN approvals, represent Regulatory on the Commercial label update team
Participate/manage minor supplements and amendments
F/U with Orange Book entries
Other regulatory projects

Skills and Requirements:

Bachelor's degree in scientific field
Two years of pharma experience and/or medical devices.
Have scientific experience
Needs to communicate well
Work in a cross-functional matrix environment
Feel comfortable presenting
Tech Savvy Systems database repository experience, need to be able to learn quick

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-SR2

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