The DLRS Associate Director serves as a recognized expert and an authoritative resource to lead the efforts of Regulatory Counsels and other professional office staff, coordinate and manage special projects as directed, and to advise others concerning FDA statutes and regulations of generic drug products. Duties include, but are not limited to:
Resolves a broad range of issues concerning the application of FDA’s enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Agency, with special focus on the Hatch-Waxman amendments.
Directs, oversees, and plans work to be accomplished by immediate subordinates, evaluating work product and performance, and providing counsel.
Oversees subordinate replies to correspondence from regulated industry and other interested parties and provides counsel as needed.
Manages the process for the development of petition responses, regulatory documents, and other written statements on Agency policy, ensuring that subordinate Regulatory Counsels have consulted with staff at all levels of the Agency to identify areas of discrepancy and that such disagreements are resolved.
Critically reviews documents written by subordinate staff that embody policy and program proposals and decisions on products.
Reviews policy and other regulatory documents drafted by other Offices that impact the generic drug review and approval process; Initiates and drafts revisions and corrections to new and existing regulatory documents which are broad in scope and generally affect the entire generic industry.
Evaluates and coordinates proposed legal actions to ascertain compliance with regulatory policy and enforcement objectives.
Assists in coordinating, interpreting, and evaluating the Office’s overall legal compliance efforts and establishes compliance policy, recommending policy to Center management, as necessary.
Initiates decision-making processes and documents and participates fully in discussions and decisions concerning OGD plans, programs, and activities both in strategic planning and in the actual determination, allocation, and administration of Center program segments, functions, and activities.
A juris doctorate degree from an accredited institution of higher learning. Knowledge of federal regulatory programs is required; knowledge of drug law is desired, and significant experience in leading employees and functioning at the managerial level is desired.
Effective communicator who can drive collaboration, empower staff, and is committed to the Public Health mission.
Demonstrated ability to identify and analyze problems; weighs relevance and accuracy of information; generates and evaluates alternative solution; make recommendations.
Ability to work independently and as a contributing, collaborative team member.
Ability to organize time effectively, determine priorities, and move work forward.
About U.S. Food and Drug Administration
The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating manufacturing, marketing, and distribution of tobacco products to protect the public health.
The Office of Generic Drugs (OGD) is responsible for the development and implementation of standards for the safety and effectiveness of generic drugs; reviews and evaluates Abbreviated New Drug Applications (ANDAs) and their amendments or supplements and determines approvability; establishes bioequivalence specifications for drug products and develops guidelines for bioequivalence reviews, industry protocols, and studies; and oversees all aspects of labeling submissions for ANDAs.