CV / English / Regulatory Affairs Associate
Personal Information
- Name: Alex R. Mercer
- Address: 456 Regulatory Lane, Compliance City, CO 12345
- Phone: (555) 123-4567
- Email: [email protected]
Brief
A dedicated and knowledgeable Regulatory Affairs Associate with over 4 years of experience in the pharmaceutical industry. Expert in FDA submissions, regulatory strategy development, and compliance management. Demonstrated ability to manage multiple projects while meeting challenging deadlines. Proven skills in effective communication and collaboration with cross-functional teams.
Core Competencies
- Regulatory Strategy & Submission
- FDA & ICH Guidelines
- Compliance Management
- Document Preparation & Review
- Project Management
- Cross-functional Team Collaboration
- Regulatory Intelligence
- Problem Solving
- Effective Communication
Technologies and Certifications
- Proficient in Regulatory Information Management Systems (RIMS)
- Experienced with eCTD Software
- Microsoft Office Suite
- Certified Regulatory Affairs Professional (RAC)
Professional Experience
Regulatory Affairs Associate
PharmaTech Solutions, Inc., Compliance City, CO June 2019 - Present - Prepared and submitted regulatory filing documents to the FDA, leading to the approval of 3 new drugs. - Conducted thorough reviews of promotional materials to ensure compliance with FDA regulations. - Developed and implemented regulatory strategies for early-stage drug development projects. - Assisted in the preparation of regulatory documentation for international markets, including the EU and Canada.
Regulatory Affairs Intern
MediQuick Innovations, Compliance City, CO January 2018 - May 2019 - Supported senior regulatory affairs associates in preparing IND, NDA, and ANDA submissions. - Collaborated with R&D and Quality Assurance teams to ensure all development activities were compliant with regulatory requirements. - Participated in regulatory intelligence activities to keep the company informed on changing regulations and guidelines.
Education and Training
Master of Science in Regulatory Affairs University of Compliance Studies, Compliance City, CO September 2016 - June 2018
Bachelor of Science in Biology Science University, Science City, ST September 2012 - May 2016
Referees
Jane Doe Senior Regulatory Affairs Manager PharmaTech Solutions, Inc. Email: [email protected] Phone: (555) 234-5678
John Smith Director of Regulatory Affairs MediQuick Innovations Email: [email protected] Phone: (555) 345-6789