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Regulatory Affairs Associate - Hawthorne, United States - SGA
Description
Software Guidance & Assistance, Inc., (SGA), is searching for aRegulatory Affairs Associate
for a
FULL-TIME
assignment with one of our premier
Pharmaceutical Services
clients in
Westchester County, NY .
Looking for someone to work on FDA labeling
This is a direct-hire, permanent position.
Client cannot sponsor Visas now or in the future.
Responsibilities :
Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.
Review labeling revisions for Firm and private label products.
Initiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS).
Convert Firm labels and customer's labels to SPL.
Prepare Drug Listings for newly approved and private label products and resolve returned listing problems.
Reserve NDC numbers for Firm and customer labeling.
Monitor FDA web sites for revisions to labeling for RLD of Firm products.
Assist with customs release inquiries.
Track and advice of all labeling revisions for incorporation into annual reports.
Respond to requests for information regarding marketed prescription and OTC products.
Maintain documents on approved and newly filed products.
Electronically search for new regulatory guidelines and regulations. Perform routine monitoring of Federal Register.
Assist with review, approval, and submission of Promotional Materials for Firm Products.
Assist with projects such as FDA inspection, teleconferences arranging webinars, etc.
Collect information to assist in compiling departmental budget.
Required Skills :
Bachelor's degree.
Minimum 1-3 years regulatory experience in the generic pharmaceutical industry.
Advanced computer skills required.
Preferred Skills :
B.A. in scientific field preferred.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business.
Our mission:
to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it.
You'll join a diverse team built on these core values:
customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at
.
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status.
We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities.
Please visit our companyto request an accommodation or assistance regarding our policy.
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