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Sr. Associate, Regulatory Affairs (Labeling)

Schaumburg, IL

Posted: 09/24/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2235

The Sr. Associate, Regulatory Affairs - Labeling will be 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.

Essential Job Functions/Responsibilities
  • Responsible for the creation of commercial, submission and deficiency labeling with a focus on ensuring that all Regulatory, Quality and Manufacturing requirements are satisfied
  • Work closely with different cross-functional groups to support NDA oncology labeling for submission/launch
  • Performs critical proofreading of label copy at all stages of the product life cycle
  • Ability to complete tasks related to label development, proofreading and copy review within specified timelines
  • Generates and maintains SPL/Drug Listing for NDA/ANDA products
  • Capable of managing basic requests for serialization tracking and DSCSA
  • Assists in the preparation and compilation of electronic submissions in eCTD
  • Examines and researches laws, regulations and guidelines governing the development/commercialization of drugs
  • May participate in project planning to ensure submission requirements and timing are in alignment with overall project timelines
  • Supports the preparation of documents as needed

Requirements / Qualifications
  • Bachelor’ s degree in a scientific discipline (Chemistry, Microbiology/Biology, Pharmacy, PreMed or Nursing)
  • 5 years' direct pharmaceutical industry experience or work experience in a cGMP and/or FDA regulated environment. Regulatory, Labeling or Quality experience preferred.
  • Knowledge of the regulatory affairs function, preferably in a pharmaceutical or FDA-regulated industry
  • Demonstrated proofreading ability
  • Excellent working knowledge of Microsoft Office software (Microsoft Word and Excel) and Adobe Acrobat
  • Experience with pharmaceutical labeling in any capacity is preferred; experience with document comparison software a plus
  • Well organized with a passion for quality and an impeccable detail orientation
  • Able to work independently and within a team environment
  • Solid interpersonal (verbal and written) communication skills at all levels
  • Thrive in, and able to work in, a fast-paced entrepreneurial environment

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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