- 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
