Regulatory Affairs Specialist
Resume:
Charles Hughes
Regulatory Affairs Specialist
Pharmaceutical and Medical Devices
Charles E. Hughes Jr.
******@*****.***
SUMMARY OF EXPERIENCE:
Regulatory Affairs Specialist, Certified Designated Representative in Florida and California for seven years, with knowledge of VAWD accreditation application and approval process, NABP, FDA, CFR, ISO13458, 510K, SOP, and cGMP standards and guidelines; safety rules and regulations; pertinent federal health and pharmaceutical policy and procedures, including extensive knowledge of pharmaceutical and medical device industry for over ten years.
Knowledge of the federal and state legislative and regulatory requirements for distributions, trace and tractability of product pedigrees via rfXcel system, communicated with legal departments to assure compliance with regulatory requirements while assuring and issuing the proper and continued state licensing requirements for all companies doing business.
Maintained library of federal and state requirements, attended regulatory seminars pertaining to jurisdiction over pharmaceutical issues. Excellent managerial and organizational skills with the capacity to handle multiple tasks, excellent oral and written communication skills; effective presentation skills; flexibility, excellent interpersonal skills, positive and collegial attitude; basic business and personal computer skills such as Word, Excel, Lotus Notes
PROFESSIONAL EXPERIENCE:
DSC/ Health Care - Roanoke Texas
2008 - Present
● Regulatory Affairs and compliancy manager for Kimberly–Clark Global Sales, LLC account, Pharmaceutical and Medical Devices Division.
● Proactively identified FDA and State operational requirements.
● Influenced weekly Regulatory meetings and provided support to operations.
● Successfully drafted, revised and updated policies and procedures and SOPs,
while ensuring the companies VAWD certification by NABP at two locations.
● Developed and implemented actions plans in respond to
regulatory operational issues governing compliance.
● Ensured track and tractability and integrity of all medical device and prescriptions drug products.
● Identified compliance with laws and regulations of 21 CRF requirements including licensing for sampling and relabeling of products.
● Reviewed internet FDA and State regulatory updates weekly.
● Established and maintained liaison with inventory managers to ensure procurement and delivery of product.
● Facility Sustainability Coordinator.
Pharma Corp Inc. - Miami Florida
2005 - 2006
● Director of Pharmaceutical Sales and Operations
Entrepreneur company in secondary wholesale distribution
● Certified Designated Representative
Med-Stat Pharmaceuticals - Fort Lauderdale Florida
2001 - 2004
● Hospital Sales Representative
Real Estate Investments - Entrepreneur
1995 - 2001
Education:
Bachelor of Science in Biology
Morgan State University
Doctoral
Life Chiropractic University
Skills:
Licensed Certified Designated Representative in Florida and California.
Solid computer skills, written and oral communication skills, Excellent people skills.
Broad base knowledge of health care and pharmaceuticals industry.
Additional Information:
Certificate of Achievement:
Department of Pharmacology of the Medical College of Pennsylvania
Certificate of Achievements:
Successful completion of curriculum in pharmacological product information and ethics
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