Regulatory Specialist

479

Lake Zurich, IL, United States
Base: $100,706.01 to $110,422.12 usd annual; bonus...
Fully remote
Prepare and file high-quality submissions
Post-approval maintenance of regulatory dossiers
Interact with regulatory agencies
The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers

Job Summary

  • The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers.
  • This position involves representing the Regulatory Affairs Department on project teams and providing regulatory guidance, as well as serving as an expert in technical areas.
  • We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Matching Summary

The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers.

Salary

Base: $100,706.01 to $110,422.12 USD Annual; Bonus/Equity: Not specified; Benefits: medical, dental and vision coverage, life insurance, disability, 401K with company contribution, wellness program

Skills & Requirements

Must-have

  • prepare and file high-quality submissions
  • post-approval maintenance of regulatory dossiers
  • interact with regulatory agencies
  • review technical documents for cGMP
  • develop regulatory strategy for difficult issues

Nice-to-have

  • train new regulatory specialists
  • support COO office on priorities
  • share best practices for planning

Key Requirements

  • Bachelor’s degree in Chemistry, Biochemistry, Biology, Biotechnology or related field
  • one (1) year of experience in pharmaceutical regulatory affairs
  • expertise preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to FDA
  • expertise successfully completing supplements and/or amendments approved by the FDA
  • expertise understanding CFR, FDA/ICH guidelines and cGMP’s

Work Rights

Not specified

Tailored Resume

Cover Letter