CV / English / Regulatory Affairs Manager
Personal Information
- Name: Sarah Langton
- Address: 342 Pine Tree Lane, Springfield, IL, 62704
- Phone: (555) 123-4567
- Email: [email protected]
Professional Summary
Dynamic and experienced Regulatory Affairs Manager with over 8 years of experience in the pharmaceutical industry. Demonstrated expertise in navigating complex regulatory environments, developing and implementing strategic regulatory plans, and leading cross-functional teams to achieve product approval and compliance. Proven track record of successfully managing multiple projects while meeting tight deadlines. Strong communicator with the ability to liaise effectively between regulatory authorities and corporate teams.
Core Competencies
- Regulatory Strategy Development
- FDA/EMA Submissions
- Cross-Functional Leadership
- Compliance Monitoring
- Project Management
- Risk Management
- Regulatory Documentation & Submission
- Team Building & Leadership
Technologies & Certifications
- Proficient in Regulatory Information Management Systems (RIMS)
- Experienced with eCTD submission software
- Certified Regulatory Affairs Professional (RAC)
- Advanced knowledge of MS Office Suite and Project Management tools
Professional Experience
Lead Regulatory Affairs Manager
Novartex Pharmaceuticals, Springfield, IL June 2017 – Present - Led the regulatory strategy and submission process for 3 new drug applications (NDAs), resulting in successful FDA approvals. - Coordinated with international partners to ensure compliance with global regulatory requirements. - Implemented a streamlined process for internal review of regulatory documents, reducing submission errors by 25%.
Regulatory Affairs Specialist
HealthCorp Inc., Chicago, IL March 2015 – May 2017 - Supported the regulatory affairs team in preparing and submitting INDs, NDAs, and BLAs with a 100% on-time submission record. - Conducted comprehensive reviews of product labeling and advertising materials to ensure compliance with regulatory standards. - Participated in cross-departmental teams to develop risk management strategies for product launches.
Education & Training
- M.S. in Pharmacy, University of Illinois at Chicago, 2014
- B.S. in Biology, Illinois State University, 2012
- RAC Certification, Regulatory Affairs Professionals Society, 2016
Referees
Dr. Jonathan Mayers Director of Pharmacy, Novartex Pharmaceuticals Email: [email protected] Phone: (555) 987-6543
Ms. Andrea Richmond Senior Regulatory Affairs Specialist, HealthCorp Inc. Email: [email protected] Phone: (555) 654-3210