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Scientific. Clinical. Software Engineering

Regulatory Affairs Specialist

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -062020-26960 Region: Edison-New Brunswick Metro Area

Job Description

Description:

Support the company Active Ingredient Solutions (SAIS) Regulatory/Quality Zone Head in the following:

Responding to US RA customer requests

o Log and track in customer database

o Hold sales and RA weekly meeting to track progress of customer requests

Review and publishing of Administrative and Technical amendments to

the FDA for SAIS Drug Master Files

o Work closely with the site to ensure document are accurate for

submissions

Respond to FDA Deficiency Letters

o Hold meeting(s) with site to discuss content of letter if needed

o Hold meeting(s) with customers affected by the deficiency letter

o Coordinate with the site timelines to respond to FDA deficiency letter

o Request publishing, review the response to ensure it is publishing ready,

and publish document to FDA

Send and track Information Letters to each Customer

Regulatory Intelligence

o Alert and inform sales managers and BU manager of US governmental

policies, FDA guidance and trends that may affect our US business


Years of Experience: 0 - 3 Years

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