Regulatory Specialist

2 months ago

Lake Zurich, United States Management Registry Inc Full time
Regulatory Specialist

Pay: $28

Shift: 1st (8a-5p M-F)

Location: Lake Zurich, IL (Hybrid – onsite 2 days per week)

Position Type: 9-mo. contract with possible extension.

In this role, you will ensure that our client, a well renown healthcare company meets all state, local, federal, international, and industrial regulations that apply to their products.

  • Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
  • Assess study results for adherence to 40 CFR EPA regulatory requirements.
  • Stay abreast of developments in GCP and federal regulations regarding clinical research.
  • Assist with QC and QA of various study relate regulatory documents and reports.
  • Assist with training and mentoring of junior regulatory specialists and assist with departmental QC and QA activities.
  • Serve as QA reviewer for application user manuals.
  • Gain a great deal of experience with new drugs and therapies in the field of oncology.
  • Improve on the strain relationship between QA and manufacturing with soft people's skills and communication.
  • Develop and deliver regulatory training of safety, chemical hazards, work instructions, human resources, quality, and ISO.
  • Facilitate activities surrounding institution closure, including patient transfer, study archival, and IRB notifications.
  • Utilize SharePoint to manage the document change control process and maintain configuration control.
  • Serve as regulatory contact person for representatives from sponsoring pharmaceutical and device firms and FDA for review of regulatory records.
  • Perform quality checks to ensure compliance with FDA regulations regarding electronic submissions and maintain expert knowledge of internal/external publishing standards.

Education & Background Requirements

  • High School Diploma or higher.
  • Microsoft Word
  • Adobe Acrobat
  • Knowledge on Bookmarking, hyperlinking.
  • Regulatory Publishing Experience in pharmaceutical industry (2-4 yrs preferred)
  • Previous work experience in Pharmaceuticals is preferred.
  • Strong Communication skills
  • Organized, detail-oriented.
  • Be a Team-player
  • DocuBridge
  • NDA/ANDA/IND
  • FDA guidances
  • eCTDManager



APPLY TODAY

Malone Workforce Solutions is an equal opportunity employer.

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