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Sr. Regulatory Associate

Company: Zachary Piper Solutions, LLC
Location: Montgomery
Posted on: November 23, 2020

Job Description:

Piper Companies is looking for a Sr. Regulatory Associate who can support in the development, review and execution of regulatory strategy to support global product development and registration for a Biotechnology Manufacturer in King of Prussia, PA area. Responsibilities for the Sr. Regulatory Associate include bull Responsible for preparing regulatory documents (i.e. IMPDCTAIND, FDA briefing packages, PIPs,PSPs, MAABLA, etc.) bull Support RA team in providing strategic input for projects in all aspects of Regulatory Affairs bull Effectively manager and liaise with external vendors bull Expected to remain on up to date global regulatory requirements bull Assist with training staff in regulatory matters Qualifications for the Sr. Regulatory Associate include bull BABS in life sciences bull Minimum 4 years in Regulatory Affairs bull Experience within biotechnologybiologicals bull Experience with EU Regulatory Affairs bull Knowledge and understanding of US, EU and ICH guidelines bull In-vitro devicecompanion diagnostic regulations a plus bull Experience working with FDA, EMA and European national agencies Compensation for the Sr. Regulatory Associate include bull PermanentFull Time bull Salary commensurate with experience (70,000 - 100,000 10 Bonus) bull Stock Options

Keywords: Zachary Piper Solutions, LLC, Montgomery , Sr. Regulatory Associate, Other , Montgomery, Alabama

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