Manager Regulatory Affairs Pharmacy/Wholesale Licensing

SUSAN E. STARMER

*** ***** **** ****, *******, MA 02451

781-***-**** • jtxzs4@r.postjobfree.com

QUALIFICATIONS PROFILE

Experienced and highly skilled regulatory compliance professional with a solid history of success ensuring the compliant distribution of pharmaceuticals and medical devices on an international level.

Overseer for all aspects of required licensing for Rx products to distributors, clinics, hospitals and home patients. Prepared and submitted state and federal regulatory applications for export /import and distribution of Rx products.

Submission experience in NDA’s, 510K’s and Establishment Registrations. Provided support for MDR’s, Rx product recalls, Rx labeling and quality control.

Prepared and submitted state and federal regulatory applications for the importation and distribution of Rx products to commercial customers and home patients.

-Solid history of expertly performing on-site inspections relating to Verified Accredited Wholesale Distributor, (VAWD), National Boards of Pharmacy (NABP), as well as individual states’ pharmacy law.

-Effectively performed due diligence audits in support of new business initiatives in regards to state and federal pharmaceutical licensing law.

-Expert in interpreting licensing laws and filing healthcare licensing applications to secure state and federal permits as well as required national accreditations.

-Extensive knowledge of government procurement, DOD, FAR, GMP regulations. Previously granted Top Secret clearance.

-Excellent interpersonal skills to foster and fortify partnerships with subordinates, colleagues and upper level management. --Worked and communicated effectively with customers, vendors, and State Board of Pharmacy officials.

Strong technical skills include MS Office Word, Excel, PowerPoint, Outlook, Access, Visio, SAP, and Lotus.

PROFESSIONAL EXPERIENCE

FRESENIUS MEDICAL CARE NORTH AMERICA, Waltham, MA

Regulatory Affairs Licensing Manager, 2001 2011

Originally started as Regulatory Affairs Assistant and worked my way up to Manager of RA Pharmacy Licensing department. Functioned as the key representative for the Medical/Regulatory Affairs department focusing on State and Federal Licensing for distribution/manufacturing facilities, drug safety, quality assurance, and Rx protocol. Initiated, designed, and implemented Rx Drug Pedigree system utilizing SAP. Direct liaison with state pharmacy boards, regulatory bodies, internal colleagues, business operations and supply chain concerning pharmaceutical products in regards to regulatory requirements. Conducted legal research of state and federal requirements to effectively address compliance issues and ensure patient safety. Proactively initiated solutions to negate Rx license compliance obstacles as well as strategies to achieve Verified Accredited Wholesale Distributor (VAWD) program standards and Rx drug traceability. Monitored, analyzed and reported license compliance trends to ensure seamless and compliant operations.

• Secured and maintained 100% VAWD, FDA, and individual state regulatory accreditations, licenses, permits, inspections and compliance requirements.

• Wrote SOP’s pertaining to the warehousing and distribution of Rx products to home patients, clinics, hospitals, and wholesalers.

• Regularly performed audits at individual pharma distribution units to assess regulatory and quality compliance system requirements.

• Established compliant solutions for integration of company’s existing and future auto-id systems and processes for pharma global supply chain operations within manufacturing plants, Rx distribution centers, wholesalers, hospitals, clinics and home patients.

• Created and implemented license tracking database to facilitate attainment and renewal of licenses from pharmacy boards and state agencies.

• Continuously researched upcoming and pending state regulations pertaining to the movement of Rx products nationally.

ADDITIONAL EXPERIENCE

BOB SAXON ASSOCIATES, Fort Lauderdale, Florida

Assistant Director – Crew Placement

Drove operations and secured performance of crew recruitment, interviewing, selection, and placement for world’s largest yacht management company with fleet value totaling over $500M.

THE ANALYTIC SCIENCES CORPORATION (TASC), Reading, Massachusetts

Government Specialist, Defense Contractor

Promoted from Subcontract Assistant charged with pricing government and commercial contracts to GP Specialist focused on driving business efforts to improve performance results in federal government audits. Responsible for management of global property file database, procurement, final disposition procedures and resolving all inventory control problems. Secured SBI – Top Secret Security Clearance.

Additional experience as Operations Manager at American Instant Printing and RFP Coordinator / Contracts Administrator at Bolt, Beranek & Newman.

EDUCATION / PROFESSIONAL DEVELOPMENT

Paralegal Certificate

MIDDLESEX COMMUNITY COLLEGE • Bedford, Massachusetts

Associate of Science in Paralegal Studies

MIDDLESEX COMMUNITY COLLEGE • Bedford, Massachusetts

(Currently pursuing Bachelor Degree)

Notary for the Commonwealth of Massachusetts

Regulatory Affairs Professional (RAPS)

Secret Security Clearance (Inactive)

References furnished upon request

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