Brooke J

@brooke_journey

Pharmacy and Regulatory Affairs Specialist

United Kingdom

English

About me

I hold a Doctor of Pharmacy degree with strong expertise in adverse drug reaction (ADR) monitoring and reporting, patient care, counseling, prescription review, and drug interaction assessment. My experience also includes FDA regulatory modules, eCTD submissions, ICH E6 and ICH E3 guidelines, and Clinical Study Report (CSR) preparation. I am passionate about Regulatory Affairs and skilled at developing GCP- and GMP-compliant clinical study reports, protocols, statistical analyses, and dossier submissions, ensuring accuracy, compliance, and high-quality documentation.... Read more

Skills