Job Summary

An analytical laboratory instrument manufacturing company has a current position open for a Remote Regulatory Affairs Process Expert.

Core Responsibilities of this position include:

• Guiding the customer in preparing data sets for new process filings and post-approval changes
• Acting as a Subject Matter Expert on validation strategies to introduce new technologies
• Acting as an internal liaison to compile complex data packages to support process optimizations

Required Skills:

• A minimum of 8 years’ experience in Quality or Regulatory affairs within the biopharmaceutical industry
• Bachelor's degree or higher in biotechnology, biochemistry, chemical engineering or equivalent
• Proven working knowledge of cGMP Quality and Regulatory requirements essential
• Fully conversant in the FDA, EMA and ICH regulatory requirements
• Detailed working knowledge of pharmaceutical validation processes and regulatory approval process
• Detailed working knowledge of US and European Pharmacopeia requirements as well as ISO guidances