2 Regulatory Affairs Associate Jobs in Hawthorne, NY
SGA is Hiring a Regulatory Affairs Associate Near Hawthorne, NY
Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Associate for a FULL-TIME assignment with one of our premier Pharmaceutical Services clients in Westchester County, NY .
We have openings, one Associate Director level and one Associate level. So if you are better suited for the Senior level role let me know.
But for the Junior level position, here are the details :
Looking for someone to work on FDA labeling!
This is a direct-hire, permanent position.
Client cannot sponsor Visas now or in the future.
Do you have a Scientific background? You will be reviewing leaflets / materials.
Interviews will occur next week!
Onsite / hybrid work is required - this is not remote
Responsibilities :
- Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.
- Prepare and submit updated labeling in eCTD format to the FDA.
- 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 - years regulatory experience in the generic pharmaceutical industry.
- Advanced computer skills required.
Preferred Skills :
- in scientific field preferred.
Job Summary
Full Time
Business Services
$73k-95k (estimate)
03/04/2024
06/25/2024
sga-arch.com
NEW YORK, NY
25 - 50
1991
$10M - $50M
Business Services
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About SGA
SGA was founded in 1991 as a full-service architecture, planning, interior design, virtual design and construction (VDC) and branded environments firm with locations in Boston and New York City. SGA is built around a strong design culture that is truly client-inclusive. Our passion for unparalleled design comes from the successful integration of creative solutions for unique client needs. ARCHITECTURE + PLANNING Our process-oriented architecture studio works with clients to create innovative, ground-breaking and sustainable design solutions for their unique programmatic, business and organizat...ional needs. With BIM, we are rapidly solving clients challenges and improving the design process. INTERIOR DESIGN Our dynamic interior design teams collaborate with clients to understand and emulate each clients unique mission, goals and corporate culture. Whether were working within previously set standards or establishing our own, our perpetual interest in your needs ensures the best new workplace for you. VIRTUAL DESIGN + CONSTRUCTION (VDC) Our VDC (Virtual Design and Construction) service allows us to deliver a more cost-effective, more streamlined process for design and construction. This project delivery method saves clients time and money, mitigates risk, and delivers innovative, progressive building solutions. SCIENCE + TECHNOLOGY PLANNING Leading edge science requires leading edge facilities to support it. Science is constantly changing and evolving, even faster than the design and build process. We at SGA work with our clients to anticipate their needs as the science develops. Whether it be an accelerator or a major corporate facility, SGA develops projects that can readily accommodate change in a clients science and business model. BRANDED ENVIRONMENTS Our in-house Branded Environments team provides strategic thinking, conceptualization and development of Communication Graphics as well as Signage Design and Wayfinding Strategies. When branding your envir
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The job skills required for Regulatory Affairs Associate include Regulatory Affairs, Customer Service, Integrity, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Associate. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Associate positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Associate, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Associate. You can explore the career advancement for a Regulatory Affairs Associate below and select your interested title to get hiring information.
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