CV / English / Regulatory Affairs Project Manager

Phone: +1 (555) 123-4567 | Email: [email protected] | Address: 324 Innovation Lane, Biotech City, NE 68123

Dynamic and detail-oriented Regulatory Affairs Project Manager with over 8 years of experience managing complex projects within the biotechnology and pharmaceutical sectors. Expert in navigating the regulatory landscape, ensuring compliance with FDA and international regulations, and leading cross-functional teams to achieve project milestones and product approvals.

Core Competencies

• Regulatory Strategy Development
• FDA & International Regulations
• Project Management
• Cross-functional Team Leadership
• Risk Management
• Submission Preparation (IND, NDA, BLA, MAA)
• Regulatory Agency Interactions
• Quality Control & Assurance

Technologies and Certifications

• Proficient in Regulatory Information Management Systems (RIMS)
• Experienced with Electronic Common Technical Document (eCTD)
• Skilled in Veeva Vault
• Certified Project Management Professional (PMP)
• Regulatory Affairs Certification (RAC)

Professional Experience

Senior Regulatory Affairs Project Manager | Biopharm Innovations, Inc. | June 2017 - Present - Led the successful preparation and submission of 5 IND applications and 2 NDA submissions, achieving 100% approval rate. - Managed regulatory strategies for projects spanning 3 continents, ensuring compliance with FDA, EMA, and PMDA regulations. - Coordinated cross-departmental teams of 20+ members, facilitating seamless communication and ensuring project milestones were met on time and within budget.

Regulatory Affairs Specialist | HealthTech Solutions | May 2015 - June 2017 - Assisted in the development and implementation of regulatory strategies for early-stage medical devices and pharmaceuticals. - Supported successful IDE and 510(k) submissions, directly contributing to a 30% increase in product approvals. - Provided regulatory guidance during project planning and development phases, reducing project delays by 25%.

Education and Training

Master of Science in Regulatory Affairs | Boston University | Graduated May 2015 Bachelor of Science in Biology | University of Nebraska | Graduated May 2013

Continuing Education: - Project Management for Regulatory Affairs Professionals Workshop | 2018 - Advanced Regulatory Strategy Seminar | 2019

Referees

Alex Rivera Director of Regulatory Affairs Biopharm Innovations, Inc. Email: [email protected] | Phone: +1 (555) 987-6543

Jamie Lin Senior Project Manager HealthTech Solutions Email: [email protected] | Phone: +1 (555) 654-3210