CV / English / Regulatory Affairs Consultant
Contact Information
- Phone: +1 (555) 123-4567
- Email: [email protected]
- Address: 1234 Regulatory Lane, Compliance City, CA 91011, USA
Professional Summary
A seasoned Regulatory Affairs Consultant with over 7 years of experience in the pharmaceutical and biotechnology sectors, specializing in regulatory strategy, submissions, and compliance. Expert in navigating the complex landscape of global regulatory requirements, Jane has a proven track record of successfully bringing products to market in compliance with FDA, EMA, and other regulatory bodies. An effective communicator, able to bridge the gap between scientific teams and regulatory agencies.
Core Competencies
- Regulatory Strategy Planning
- FDA and EMA Submissions
- Compliance and Risk Management
- Clinical Trial Applications
- Global Regulatory Requirements
- Project Management
- Cross-functional Team Leadership
Technologies & Certifications
- Proficient in Document Management Systems (e.g., Veeva, Documentum)
- Skilled in Regulatory Information Management Systems (RIMS)
- Certified Regulatory Affairs Professional (RAC)
- Advanced knowledge of Microsoft Office Suite
- Certified in Project Management (PMP)
Professional Experience
Lead Regulatory Affairs Consultant XYZ Pharma, Inc., San Francisco, CA January 2018 - Present Led regulatory strategy for key products, resulting in successful FDA approval and EMA marketing authorization. Managed regulatory submissions, including INDs, NDAs, and MAAs.
Regulatory Affairs Specialist Biotech Solutions Corp., Los Angeles, CA June 2016 - December 2017 Prepared and reviewed regulatory documentation for clinical trials. Supported global submissions and liaised with regulatory agencies.
Junior Regulatory Affairs Associate MedDevices, Inc., San Diego, CA May 2014 - May 2016 Assisted in the compilation of regulatory submission packages and tracked regulatory commitments and deadlines.
Education & Training
Master of Science in Regulatory Affairs University of California, San Francisco, CA Graduated: May 2014
Bachelor of Science in Biology University of California, Los Angeles, CA Graduated: May 2012
Referees
Available upon request.