CV / English / Regulatory Affairs Specialist

Samantha Bright

Address: 452 Elm Drive, Bakersville, NC, 28705

Phone: (555) 123-4567

Email: [email protected]

Dedicated Regulatory Affairs Specialist with over 5 years of experience in the pharmaceutical industry, specializing in ensuring compliance with global regulatory guidelines and facilitating effective communication between regulatory bodies and research teams. Adept at dossier compilation, submission, and management of regulatory documentation. Proven track record in successfully managing regulatory strategies and submissions for new product registrations, as well as life-cycle management of pharmaceutical products.

• Regulatory Strategy Development
• Dossier Compilation & Submission
• Regulatory Documentation Management
• Compliance Analysis & Enforcement
• Cross-functional Team Leadership
• Global Regulatory Submissions
• Post-market Surveillance & Vigilance Reporting
• Continuous Legislative Monitoring

• Technologies: eCTD Software, Document Management Systems
• Certifications: RAC (Regulatory Affairs Certification), Certified in Healthcare Compliance (CHC)

XYZ Pharmaceuticals, Durham, NC

Regulatory Affairs Specialist | June 2018 - Present - Developed and executed regulatory strategies for new and existing products. - Managed the preparation and submission of regulatory documents in accordance with the FDA, EMA, and other regulatory bodies. - Coordinated with cross-functional teams to ensure timely and compliant product launches. - Monitored and analyzed regulatory legislation activities affecting the pharmaceutical industry.

ABC Therapeutics, Raleigh, NC

Regulatory Affairs Associate | July 2015 - May 2018 - Assisted in the compilation of regulatory submissions. - Supported regulatory compliance activities and maintained up-to-date knowledge of global regulatory requirements. - Facilitated communication between the regulatory department and other departments within the company.

• Master of Science in Regulatory Affairs, Boston University, Boston, MA | 2015
• Bachelor of Science in Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC | 2013

• Jordan Miles Director of Regulatory Affairs, XYZ Pharmaceuticals Email: [email protected] Phone: (555) 987-6543

• Linda Kearns Senior Regulatory Affairs Manager, ABC Therapeutics Email: [email protected] Phone: (555) 678-1234