| Associate
Director Regulatory Compliance
The Assoc. Director of
Regulatory Compliance
will review clinical study protocols, reports,
and new investigator submissions, drug
orders and assess compliance with regulatory guidelines, cGCPs and SOPs. Perform audits
and inspections of clinical investigator sites,
in-house systems and documentation.
Coordinate the Regulatory/Legal review of
sales aids, meeting programs, training materials,
press releases, publications, etc. Assess risks,
seek advice from outside consultants as
appropriate. Prepare DDMAC/APLS submissions. Oversee product labeling preparation and
revisions, UPC/NDC codes, and drug listings.
Design and establish document and submission templates in compliance with FDA CDER/CBER
electronic submission guidelines.
Requirements: BS/BA plus 3
years or more in
R/A or equivalent in drug development. Recent hands-on experience with marketed product
promotional material review. Strong computer
skills including familiarity with electronic file management software such as ADOBE
Acrobat applications for portable document file format.
Solid understanding of FDA regulations and
guidelines.
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