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Sr. Associate, Regulatory Affairs (Labeling)

Schaumburg, Illinois

Post Date: 07/27/2017 Job ID: 1354 Job Category: Clinical: Regulatory

Our client, a specialty oncology pharmaceutical company, focuses on the development and commercialization of next generation therapies for cancer diseases and supportive therapies. 

Currently expanding its Regulatory team and is searching for a Sr. Associate, Regulatory Affairs (Labeling) in our newly formed Specialty Products Division. This operating unit will add products which are used in combination with our innovative drug candidates or therapeutically important to cancer patients. This position ultimately reports to the Vice President, Regulatory Affairs.

Incumbent responsible for the support of label creation, development and review, including assistance with submission, deficiency and commercially available labeling updates based upon partner or FDA requests. Key activities include, but are not limited to, label version creation, critical proofreading review and edit changes.


Success in the role is measured on:
  • Timely and accurate completion of assigned tasks related to label development, proofreading, and copy review.
  • Minimal internal reworks with a continued focus on quality of labeling reviews.


Job Responsibilities:
  • 50% - Proofreading label copy at all stages of the product life cycle.
  • 50% - Creation of commercial, submission and deficiency labeling with a focus on ensuring that that all Regulatory, Quality and Manufacturing requirements are satisfied.


Qualifications/ Requirements:
  • Bachelor’ s degree preferred, or equivalent cGMP related work experience. Science background degree preferred (Chemistry, microbiology/biology, pharmacy, premed, or nursing)
  • Experienced in the use of PC-Based word processing software, databases and spreadsheets (Microsoft Office Word and Excel preferred), and Adobe Acrobat. Experience with pharmaceutical labeling in any capacity is preferred. Experience in document comparison software a plus.
  • 3 to 5 or more years of direct pharmaceutical industry experience OR work experience in a cGMP and/or FDA regulated environment. Regulatory or Quality experience preferred.
  • Demonstrated proofreading ability
  • Passion for quality and an impeccable detail orientation
  • Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
  • Solid interpersonal (verbal and written) communication skills at all levels.
  • Thrive in, and be able to work in, a fast paced entrepreneurial environment with broad responsibilities



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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