Regulatory Affairs Associate
COMPANY DESCRIPTION: Generic Specialties, Inc., based in Orlando, FL is a rapidly growing
specialty pharmaceutical company focused on the development, acquisition, licensing, sale and marketing of both generic and legacy branded pharmaceuticals for the global prescription drug market.
TITLE: Regulatory Affairs Associate
JOB DESCRIPTION: The Regulatory Affairs Associate will be responsible for the creation and update of
regulatory submissions in accordance with templates and defined electronic submission standards (i.e.
hyperlinks, bookmarks, publishing). The Regulatory Affairs Associate will report directly to the Director of Regulatory Affairs and shall be located at the Company’s Orlando headquarters.
Key responsibilities shall include:
- Compilation and publication of appropriate regulatory documents individually or through other departmental personnel and/or CROs in a timely manner.
- Review of labels and package inserts and assist in Drug Listing activities.
- Identify the required documentation for submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Perform critical reviews of documentation to assure consistency of regulatory filing and to identifypotential gaps for technical liaisons in partner companies.
- Maintain the project planning system for assigned projects/products and identify quality and/or timeliness issues with source documents, as early as possible.
- Performs assigned product publishing, formats eCTD templates, and coordinates submission activities.
- Maintain e-submission standard documents and check lists to ensure consistency with FDA Guidance’s, cross functional documentation and other Internal and External groups.
- Develop up to date knowledge with regard to guidelines and regulatory as well as technical trends.
- Raises major project issues to Senior Management for resolution and agreement.
- Maintains the RA Document File Room.
- Degree in Science (e.g. Pharmacy, Chemistry, Biology, Biochemistry) or equivalent
- 3+ years practical experience (Regulatory , Chemical/Biotech, Development or Quality Assurance)
- 3+ years knowledge of CMC regulatory and/or CMC documentation preparation experience.
- Strong working knowledge of Microsoft Office and desktop publishing. Electronic submission experience preferred.
- Good interpersonal, communication and organizational skills.