Summary
Experienced regulatory affairs specialist skilled in regulatory submissions, FDA regulations, and product registration. Strong communicator with a record of managing documentation and collaborating across teams to deliver compliant, on-time results.
Experience
- Coordinated regulatory submissions to the FDA, achieving approval for four new products in two years.
- Analyzed and interpreted federal and local regulatory requirements, reducing compliance issues by 25%.
- Assessed regulatory impact of labeling and process changes, preventing three potential product launch delays.
- Attended research team meetings and reported regulatory issues, improving cross-team communication.
- Assisted in preparing regulatory submissions, resulting in faster review cycles.
- Calibrated and troubleshot analytical instruments, reducing downtime by 10%.
- Supported Good Clinical Practice (GCP) documentation, passing all external audits.
Education
Courses
- Certified Clinical Research Professional (CCRP), SOCRA