Regulatory Compliance Change Assessor - Sr Associate

• Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope.
• Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system.
• Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies.

Basic Qualifications:

• Master's degree
• Bachelor's degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
• Associate's degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
• Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

• Degree in Life Science discipline
• Regulatory CMC specific knowledge & experience
• Understanding and application of principles, concepts, theories and standards of scientific/technical field
• Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry