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Associate, Regulatory Affairs Post Approval

Schaumburg, IL

Posted: 05/16/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2357
Our Client is looking to add an Associate, Regulatory Affairs to its team on a permanent basis. The person in this role will be responsible for support of post-approval regulatory affairs activities under direction of the department Manager. Post-approval regulatory affairs activities may include Compilation/review of Annual Reports, Advertising/Promotional material, and product labeling; Electronic assembly and publication of original applications, amendments, and supplements; and, Assessment of proposed changes to manufacturing facilities, processes, and/or controlled documents.
Success in the role is measured by:
  • Timely and accurate pre-submission review and electronic filing of FDA submissions including ANDAs, 505(b)(2)s, Amendments, Supplements, Annual Reports, DMF updates, labeling changes, and Advertising/Promotional material
  • Timely and accurate review of change controls according to regulatory guidelines.

Key Duties and Responsibilities:
  • Compilation and review of FDA Submissions (e.g., Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with partners; and change control review/approval;
  • Coordinate compilation/review of Advertising/Promotional material with Marketing for Manager’ s review and approval. Submit Advertising/Promotional materials to FDA’ s OPDP via electronic methods.
  • Domestic and international travel may be required.

Requirements / Qualifications:

 
  • Bachelor’ s degree in a scientific area of interest (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing) or equivalent work experience.
  • 2 or more years of direct pharmaceutical industry experience OR equivalent experience working in a cGMP and/or FDA regulated environment is preferred.
  • Experience in the use of PC-based word processing software, databases, spreadsheets and Adobe Acrobat, including database management and support.
  • Experience with metrics management and reporting.
  • Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred.
  • Excellent communication skills with both internal and external stakeholders.
  • Strong planning and organizational skills.
  • Ability to work under deadline pressure, rapidly shifting priorities and manage multiple projects.
  • Strong ability to work independently as well as in a team environment.
  • Ability to drive projects to completion with minimal guidance.
  • Formal project management skills are a plus.

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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