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Senior Associate, Regulatory Affairs Post Approval

Schaumburg, Illinois

Post Date: 08/04/2017 Job ID: 1608 Job Category: Clinical: Regulatory

Responsible for support of post-approval regulatory affairs activities under direction of the department Manager.  Post-approval regulatory affairs activities may include but are not limited to:
  • Compilation/review of Annual Reports, Advertising/Promotional material, and product labeling
  • Electronic assembly and publication of original applications, amendments, and supplements
  • 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 ANDA’ s, 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. 

Job Responsibilities:
  • Post-approval product support activities:  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.

Qualifications/ Requirements:
  • Bachelor’ s degree in a scientific area of interest (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing) or equivalent work experience preferred.
  • 4 or more years of direct pharmaceutical industry experience OR solid equivalent experience working in a cGMP and/or FDA regulated environment.
  • Direct responsibility for post-approval submissions to FDA, and for submitting ad/promo materials to FDA as well as hands-on experience reviewing and approving ad/promo materials.
  • Strong planning and organizational / project / workload management 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.
  • Solid interpersonal (verbal and written) communication skills at all levels.
  • Formal project management skills are a plus.
  • Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry is a plus.Regulatory publication experience using eCTD software is a plus.
  • Experience in the use of PC-based word processing software, databases, spreadsheets and Adobe Acrobat, including database management and support.
  • Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred.
  • Experience with metrics management and reporting.
  • Proven negotiation skills with internal and external stakeholders.  

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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