Legal Career Center

Duties/Responsibilities:

• Manages and resolves a broad range of issues concerning the implementation of FDA's enabling statutes, including those related to generic drug regulation and the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, pertinent regulations, guidance documents, standard operating procedures, and other policy documents related to the regulation of generic drug products.
• Develops policies and programs involving the most complex and highest priority matters affecting the regulation of generic drug products. Drafts or critically reviews documents embodying policy and program proposals and decisions on these products. These documents state or interpret Center or FDA policy for the regulated industry and other affected groups and receive minimal review before transmittal to management or other stakeholders.
• Leads multi-disciplinary working groups to develop policy regarding generic drug regulation through consensus building. Drafts, revises and issues technical corrections to new and existing regulatory documents.
• Reviews policy and other regulatory documents drafted by other Offices that impact generic drug regulation.
• Serves as an expert consultant on the generic drug regulatory review process within FDA and to other interested groups.
• Prepares replies to correspondence from the regulated industry and other interested persons on issues that are industrywide in scope or have broad health-policy implications and that concern precedent-setting interpretations of FDA policy.
• In developing regulatory documents and other written statements of Agency policy, consults with staff at all levels of the Agency to identify areas of disagreement between components, resolve disagreements using decisional memoranda or meetings, and articulate any policy consensus reached through this process.
• Coordinates and manages special projects as assigned and advises others concerning FDA statutes and regulations pertaining to generic drugs.
• Researches and resolves regulatory issues related to information that is published in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

Professional Experience/Desirable Qualifications:

• Knowledge of federal regulatory programs is required; knowledge of drug law is desired.
• Significant experience leading projects independently with minimal supervision is desired.
• Possession of significant knowledge of regulatory practice, policies, and procedures, with experience related to the Hatch-Waxman Amendments and the generic drug program highly desired.
• Demonstrated ability to identify and analyze problems; weigh the relevance and accuracy of information; generate and evaluate alternative solutions; and make recommendations.
• Expert ability to communicate and work with staff at all levels of the organization and varying levels of domain expertise; demonstrated ability to collaborate across boundaries to build strategic relationships and achieve common goals.
• Ability to work independently and as a contributing, collaborative team member.
• Ability to organize time effectively, determine priorities, and move work forward.

Key requirements will include:

5 years in an attorney or regulatory professional role providing advice on federal regulatory issues.  Experience practicing food and drug law in a law firm, government agency, or in-house in the pharmaceutical industry is highly desired.

Desirable Education:

A juris doctorate degree from an accredited institution of higher learning.