CV / English / Regulatory Affairs Director

Elizabeth Harmon

2345 Regulatory Lane, Compliance City, KY 12345 Email: [email protected] | Phone: (555) 123-4567

Dynamic and strategic Regulatory Affairs Director with over 12 years of comprehensive experience in managing regulatory processes, compliance, and submissions within the pharmaceutical industry. Demonstrated success in developing regulatory strategies, leading cross-functional teams, and ensuring products meet all regulatory standards from conception to market. Adept at navigating complex regulatory landscapes and fostering relationships with key stakeholders, including regulatory agencies.

Core Competencies Include: - Regulatory Strategy Development - FDA and International Regulatory Laws - Product Approvals and Launches - Team Leadership and Training - Regulatory Documentation and Submissions - Compliance Management - Stakeholder Engagement - Cross-functional Teamwork

Technologies and Certifications: - Proficient in Regulatory Information Management Systems (RIMS) - Experienced with eCTD software and submission tools - Certified in Regulatory Affairs (RAC) by the Regulatory Affairs Professionals Society (RAPS) - Advanced knowledge of GMP, GLP, and GCP

Professional Experience

VitaPharma Corporation, Lexington, KY Regulatory Affairs Director January 2018 - Present - Led the strategic planning and execution of global regulatory initiatives, achieving a 40% reduction in product approval times. - Managed a team of 20 regulatory professionals, guiding product lifecycle from development to market. - Successfully launched 5 new products in the U.S. and 3 in the EU, adhering to stringent regulatory requirements.

HealthMed Devices, Louisville, KY Senior Regulatory Affairs Manager May 2012 - December 2017 - Oversaw regulatory submission processes, ensuring compliance with FDA and international regulations. - Developed and maintained productive relationships with FDA and other regulatory agencies. - Implemented process improvements in documentation practices, resulting in a 25% increase in efficiency.

Education and Training

Master of Science in Regulatory Affairs Boston University, Boston, MA Graduated: May 2011

Bachelor of Science in Pharmacy University of Kentucky, Lexington, KY Graduated: May 2007

Continuing Education: - Regular attendance at RAPS Conferences and Workshops - Completed several courses on regulatory compliance and global strategies through Coursera.

Referees Available Upon Request

Note: References include former supervisors and a respected industry expert. Contact information can be provided if necessary for the application process.