Regulatory Affairs Specialist Job

REGULATORY AFFAIRS SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Swiftwater, PA.

WHAT YOU'LL BE DOING:

- Work with Contract Research Organization (CRO) colleagues to gather backlog of international MoH (Ministry of Health) Clinical Trial Application submissions/correspondence and enter into document management and tracking systems
- Assure submission files, communications, etc. are properly archived and tracked in RA systems on a Real Time basis
- Prepares and coordinates the creation of clinical trial applications, amendments and other regulatory submissions for regulatory authorities and/or third parties.
- Organizes the compilation of a submission. May provide editorial review for components of regulatory submissions.
- Archives and tracks all submissions

WHAT YOU NEED TO BRING TO THE TABLE:

- BA/BS and/or MS in Biology, Life Science or related field of study.
- Three to five (3-5) years prior Regulatory Affairs experience
- Working knowledge of Microsoft Word, Excel, Project experience with or ability to learn regulatory affairs department systems (eg document management and tracking systems)
- Experience working on teams

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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