CV / English / Regulatory Affairs Coordinator
Personal Information
- Name: Jane Sterling
- Address: 254 Harmony Road, Regulaville, RX 90210
- Phone: (555) 123-4567
- Email: [email protected]
Summary
Dynamic and detail-oriented Regulatory Affairs Coordinator with over 5 years of experience in ensuring regulatory compliance across pharmaceutical products. Proficient in drafting and reviewing regulatory documents, coordinating submissions, and liaising with regulatory agencies. Demonstrated ability to manage multiple projects while maintaining high standards of compliance. Skilled in regulatory strategy development and execution, aiming to facilitate product market entry while ensuring full compliance with applicable regulations.
Core Competencies
- Regulatory Strategy & Compliance
- Document Preparation & Submission
- International Regulations (FDA, EMA, Health Canada)
- Project Management
- Team Leadership & Collaboration
- Effective Communication
- Problem Solving & Analysis
Technologies & Certifications
- Regulatory Databases: Documentum, Veeva Vault
- Software: Microsoft Office Suite, Adobe Acrobat Pro
- Certifications: Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA)
Professional Experience
Advanced Pharma Solutions, Regulaville, RX
Regulatory Affairs Coordinator October 2018 - Present - Coordinated the preparation and submission of regulatory documents for over 30 drug applications, contributing to a 95% approval rate on first submission. - Led cross-functional teams in the development of regulatory strategies to facilitate product launches in new markets. - Maintained up-to-date knowledge of international regulatory requirements, ensuring all products complied with FDA, EMA, and Health Canada guidelines. - Implemented a tracking system for regulatory submissions which reduced document retrieval times by 40%.
BioReg Pharma, Metropolis, MY
Regulatory Affairs Associate January 2016 - September 2018 - Assisted in the preparation and submission of regulatory documents for new drug applications and post-marketing commitments. - Conducted thorough regulatory reviews of promotional materials to ensure compliance with applicable laws and regulations. - Participated in regulatory agency meetings and provided detailed meeting reports and action points to internal teams.
Education & Training
- Master of Science in Regulatory Affairs, University of Sciences, Philadelphia, PA Graduated: May 2015
- Bachelor of Science in Biology, Rivertown University, Rivertown, RI Graduated: May 2013
Referees
Available upon request.