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 platform technologies, secure supply chains and meet quality expectations. Joy’s tenure with the FDA included service in CDER in OPQ's Ofc. of Policy for Pharmaceutical Quality and Office of Compliance; Ofc. of Food Policy and Response (Commissioner's Ofc.); CFSAN, Ofc. of Director; Ofc. of Regulatory Affairs, Office of [Enfcmt &] Import Operations While at the FDA, Joy advised on many aspects of drug and biological product policy, including inspectional authority, product jurisdiction, statutory authority, and applicability of current regulatory regime to various Agency initiatives (e.g., FRAME (Advanced Manufacturing), platform technology designation program; quality metrics (QM)/ quality management maturity (QMM). Joy advised senior imports and field leadership in the areas of imports review process, sampling strategy, import alerts and administrative detention, prior notice, and ACE, e.g. Joy also supported implementation of FDA’s New Era of Smarter Food Safety, Food Safety Modernization Act, and FDA’s Strategy for the Safety of Imported Food.With her FDA regulatory experience, Joy provides insight on CGMP for small and large molecule drug product, drug substance/API, and excipient manufacturers, e.g., ICH quality guidelines, inspectional policy, recalls, PM reporting, QM/QMM initiatives, GGP, etc. For food and beverage industry, FSMA's foundational rules (PC, Produce Safety, FSVP, Accredited 3P Cert., VQIP, traceability, etc.)Prior to her work with the FDA, Joy spent nearly a decade as in-house transportation attorney (air freight-forwarding, ground carriage), e.g., as AGC for Walmart T&L in Bentonville, AR

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 Quality Voice” strategy to design a uniform drug quality program across all sites of manufacture -- domestic or foreign -- and across all human drug product areas including new drugs and biologics, generics, biosimilars, OTC drugs and compounded drug products.§ Serve as mentor and SME to team members. § Provide legal counsel as to methods for encouraging adoption of best practices for pharmaceutical development, application submission and review, manufacturing, distribution, risk management, corporate quality culture, PQS approaches, incorporating emerging technologies. Areas of concentrated involvement: § Quality metrics, with practice areas such as PQS effectiveness and quality risk management§ Biological product review standards, first licensure exclusivity requirements, defining “highly similar” and other standards for biosimilars, interchangeability and related exclusivity, and interplay with orphan drug and other exclusivities.§ Current good manufacturing practice (CGMP) for drugs, including homeopathic, OTC monograph, application products, biologics and small molecule, therapeutic and drug substance components. § Homeopathic CGMP standards for component and finish product providers.§ The Committee for Foreign Investment in the United States (CFIUS) – Lead for all OPQ responses; investigate proposed foreign investments in U.S. involving or potentially affecting the security of pharm supply chains and/or the supply of quality drugs to U.S. consumers. March 2022: FDLI, Intro to Regulation of Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advance

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 guidance) – review, preparation of briefing slides, and other participation.§ Workgroup Lead – Standards Alignment Pilot – Pilot for FDA SME review and assessment of alignment of submitted food safety schemes with the provisions of the produce safety rule (PSR) and the preventive controls for human food production rule (PCHF). Cross-center collaboration with the FDA Accredited Third-Party Certification Program (ATPCP).§ Workgroup Lead – AI/ML imported seafood screening and analytics pilot project (proof of concept): Project manage/co-lead non-operational outputs of WG comprising center senior leadership (ORA, OIMT) and CFSAN SMEs. Draft pilot overview proposal, timeline, internal/external communications.§ AI (machine learning) proposals: (1) to use ML in the process for screening imported food, and (2) to improve customer service and efficiency of the technical assistance network.§ Tableau Advanced Training – October 2020§ Third-Party Food Safety Standards Alignment Initiative: Legal analysis for senior leadership; Drafted five-year resource projection and budget;§ Proposed blockchain program to executive leadership, founded on the premises of supply chain security, imported food safety assurance, transparency to FDA, and need-to-know visibility to members designed to protect commercial confidential information. § Legal analysis for leadership related to the regulation and the launch of New Era of Smarter Food Safety.§ Developed strategy structure and content for OFVM. This included proper import screening systems and met…other

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, focused on imported food and dietary supplements. Managed program interactions to ensure efficient use of assets across multiple groups. Key Contributions:• 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 Integration.• 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 citizens questioning animal testing and studies regarding marijuana. Consistently elevated public health over business needs.Key Contributions:• 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 uncovered by the research and deep investigation.

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 refining various targets.Key Contributions:• 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 regulations. Reviewed all internal and external correspondence. Developed and drafted drug safety bills. Worked to solve multiple sensitive and complex issues within the division. Strengthened communications across FDA product centers and offices by combining key initiatives. Key Contributions:• 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