Regulatory Specialist

3 weeks ago


St Paul, United States Bell International Laboratories Full time

The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements.

Responsibilities

  • Support our customers through provision of requested regulatory documentation.
  • Coordinate and prepare routine submissions for FDA and other regulatory entities.
  • Monitor applicable regulatory requirements to assure compliance with domestic and foreign regulatory standards.
  • Maintain regulatory approvals and associated files. Build and maintain “regulatory library”.
  • Provide regulatory feedback to R&D regarding proposed product ingredient lists.
  • Evaluate customer artwork for adherence to regulatory compliance.
  • Support R&D during development process to ensure formulas are compliant in the applicable regulated countries.
  • Identify and create efficiencies in the facilitation of regulatory processes.
  • Actively participate in internal audits, customer audits and other activities as assigned by manager.

Required Skills/Abilities

  • Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
  • Ability to effectively build and maintain relationships, communicating and interacting in a matrix environment.
  • Strong organizational skills, with a keen eye for reviewing and editing documents.
  • Ability to maintain meticulous attention to detail and precision while juggling multiple tasks.
  • Excellent written, verbal and interpersonal communication skills
  • Proficiency in Microsoft Office and Adobe Acrobat

Required Education and Experience

  • BS/BA in science, engineering, quality/regulatory studies, or equivalent industry experience in pharmaceutical regulatory affairs.
  • A quality professional with 2-5 years of hands-on experience in regulatory management within the regulated pharmaceutical industry, including direct regulatory experience.

Preferred Education and Experience

  • Exhibit a quality mindset and a willingness to develop yourself and others.
  • Demonstrated knowledge of GMPs, 21 CFR 210 and 211 and other regulatory agency requirements sufficient to apply to quality operations and compliance.
  • Audit or inspection experience preferred.


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