Regulatory Affairs Specialist Resume
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Charles Bloomberg
PROFESSIONAL SUMMARY
Experienced Regulatory Affairs Specialist with a strong track record in compliance, documentation, and regulatory submission processes within the pharmaceutical and medical device industries. Proficient in ensuring products meet all applicable regulatory standards and maintaining meticulous records.
PROFESSIONAL Experience
Regulatory Affairs Specialist | Company A
January 2020 — Present, New York, USA
• Managed regulatory submissions for over 25 pharmaceutical products annually, ensuring 100% compliance with FDA, EMA, and other international regulations.
• Conducted detailed regulatory analysis and prepared comprehensive documentation, reducing approval times by 30% over two years.
• Led cross-functional teams to address regulatory issues, resulting in the smooth launch of three high-profile drugs within the projected timelines.
• Utilized regulatory software (e.g., eCTD, RIMS) to streamline submission processes, achieving a 20% increase in efficiency.
• Developed and maintained Standard Operating Procedures (SOPs), ensuring alignment with current industry standards and best practices.
• Conducted detailed regulatory analysis and prepared comprehensive documentation, reducing approval times by 30% over two years.
• Led cross-functional teams to address regulatory issues, resulting in the smooth launch of three high-profile drugs within the projected timelines.
• Utilized regulatory software (e.g., eCTD, RIMS) to streamline submission processes, achieving a 20% increase in efficiency.
• Developed and maintained Standard Operating Procedures (SOPs), ensuring alignment with current industry standards and best practices.
Regulatory Affairs Associate | Company B
May 2016 — December 2019, Minneapolis, USA
• Coordinated regulatory submissions for Class II and Class III medical devices, leading to successful market entry in 15 countries.
• Reviewed and approved promotional materials to ensure they met regulatory requirements, resulting in zero non-compliance issues over three years.
• Assisted in developing regulatory strategies for 10 new product lines, decreasing time-to-market by 25%.
• Monitored and interpreted regulatory changes, updating internal teams and documentation accordingly to maintain compliance.
• Reviewed and approved promotional materials to ensure they met regulatory requirements, resulting in zero non-compliance issues over three years.
• Assisted in developing regulatory strategies for 10 new product lines, decreasing time-to-market by 25%.
• Monitored and interpreted regulatory changes, updating internal teams and documentation accordingly to maintain compliance.
Regulatory Affairs Coordinator | Company C
August 2014 — April 2016, Dallas, USA
• Prepared and submitted regulatory documents for over 50 product variations, maintaining a 98% approval rate.
• Collaborated with R&D and QA teams to resolve regulatory issues in a timely manner, enhancing product quality and compliance.
• Maintained regulatory databases and tracking systems, ensuring real-time updates and accuracy of records.
• Collaborated with R&D and QA teams to resolve regulatory issues in a timely manner, enhancing product quality and compliance.
• Maintained regulatory databases and tracking systems, ensuring real-time updates and accuracy of records.
Regulatory Affairs Assistant | Company D
June 2012 — July 2014, San Diego, USA
• Assisted in the preparation of regulatory submissions, leading to timely market approval of five new products.
• Engaged in comprehensive literature reviews and regulatory research to support submission documentation.
• Managed regulatory correspondence and maintained document control, ensuring thorough compliance with industry regulations.
• Engaged in comprehensive literature reviews and regulatory research to support submission documentation.
• Managed regulatory correspondence and maintained document control, ensuring thorough compliance with industry regulations.
Education
Bachelor of Science in Regulatory Affairs | Northeastern University
May 2012
Expert-Level Skills
Regulatory Submissions, FDA Regulations, EMA Compliance, eCTD, RIMS, Documentation Control, Standard Operating Procedures (SOPs), Regulatory Strategy, Promotional Material Review, Product Launch, Cross-functional Collaboration, Compliance Training
