Joy Sharp Email & Phone Number

Washington, DC, US

Washington, DC

With 15 years of experience in the Food and Drug Administration, Joy brings a wealth of specialized legal and regulatory knowledge to the table for regulated industry, particularly manufacturers of drugs, biologics, medical devices and combination products; importers of food and other regulated products; and companies seeking to optimize and market.

White Oak, Maryland, United States

§ Member of the Regulatory Counsel Team within the Immediate Office (IO) of OPPQ, providing legal counsel to OPQ clients (IO and suboffices) on legal authority and legal and policy matters affecting drug and biological product assessment, pre-approval and surveillance inspection and record production, quality metrics-related initiatives within CDER’s “One.

White Oak, MD

§ Drafted and published FDA’s Strategy for the Safety of Imported Food§ Workgroup Lead - Import Certification (Food Safety Modernization Act (FSMA), Section 303) – legal analysis and project process. Advising senior leadership of legal implications; Consideration for use to achieve removal from import alerts; Internal procedure (proposed to replace.

College Park, MD

• Located within the Center Director’s Office, with a focus on implementing and integrating new agency authorities in a way that was not redundant. Spearheaded strategic planning for the Import Integration Program.
• Drafted concept of operations paper that advised a path forward for successful strategy implementation. Presented to the Center Director, the Deputy Center Director, and the Assistant Commissioner for Food Safety.
• Designed an interactive, user-friendly platform with the Commissioner’s Office to provide the public with data regarding imported food.
• Led program promotion across the organization, including developing a relationship within the Foreign Supplier Verification Program, Export Certificate program (international affairs office) and Third-Party Program.
• Provided career development to administrative staff and helped to broaden skillsets and identify strengths that would best suit the company’s objectives.
• Renegotiated terms of Import Certification document that avoided a possible inquiry into statutory directive failures.

Rockville, MD

• Conducted significant legal research and briefings to further program objectives and ensure compliance with agency priorities. Drafted high-level legal correspondence for the organization. Responded to petitions of.
• Executed strategy proposals regarding ORA program alignment and OEIO reorganization.
• Investigated and analyzed proposed solutions to injunctions process challenge and provided legal counsel to support a positive solution.
• Exposed misreporting of resource allocation. Thorough investigation which lead to realization that goals were set at an unrealistic level. Drafted options paper with recommendations on how to best solve the issues.

White Oak, MD

• Represented CDER’s Office of Compliance on legislative and compliance-related projects. Worked closely within the Policy and Communications Team. Created proposals meant to improve public health by modifying and.
• Completed the Leadership Development Program.
• Proposed a new senior leadership program to improve regulatory compliance by increasing presence of senior leaders in field offices.
• Designed and implemented the Drug Shortage Award program with Deputy Director of the Office of Compliance and the Drug Shortage Staff.

White Oak, MD

• Served as a member of the Senior Management Team, providing legal research and counsel on industry good manufacturing practice, adverse event reporting, and risk evaluation and mitigation strategy (REMS) policy and.
• Reviewed OMPQ advisory actions (warning letters, e.g.) and provided legal recommendations.
• Managed the OMPQ’s Congressional and press inquiry response project, writing responses to all inquiries (over 100 press inquiries in 2012).
• Successfully spearheaded the 2010-2012 GMP WL project, providing analysis that led to assistance with GMP violations, press statistics, and management of policy application across the industry.

Doctor Of Law (J.D.)

Bachelor Of Arts (B.A.), International Relations