Role Overview:
Scientific Protein Laboratories is looking for a Regulatory Affairs Specialist to support daily regulatory affairs activities for SPL and customers, focusing on compliance with FDA and international regulations. Manage regulatory documents like Drug Master Files (DMFs), maintain timelines, and assist with inspections and regulatory submissions (eCTD). Communicate effectively with internal teams, customers, and regulatory agencies.
Key Responsibilities:
- Prepare and maintain global regulatory documents and DMFs.
- Stay current on FDA, EC, USDA, and other regulatory requirements.
- Support inspections and review quality system documents for regulatory impact.
- Manage regulatory timelines independently and assist with electronic submissions.
- Assist with annual product reviews and regulatory updates.
Requirements:
- Bachelor’s degree in a scientific or related field.
- 2+ years of GMP experience.
- Strong communication, writing, attention to detail, and critical thinking skills.
Job sourced from Scientific Protein Laboratories.