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This position is located in the Office on New Drugs, Office of Antimicrobial Products, Division of Antiviral Products.
Who May Apply: This vacancy is open to current OND employees with competitive status only. Competitive status refers to employees who are serving on a career or career conditional appointment.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE)
This position is located at the FDA, White Oak Campus in Silver Spring, MD .
This announcement may be used to fill multiple positions in multiple locations.
Provides direction, oversight and leadership to subordinate Consumer Safety Officers and Regulatory Health Project Coordinators/Managers and Senior Health Regulatory Managers in the following functions:
Manages drug review process for multiple classes of drugs from initial submission to the time of approval, termination or withdrawal.
Communicates with industry on regulatory issues in order to resolve issues related to applications, facilitate technical information gathering for reviewers to ensure compliance with all legal, regulatory and policy requirements.
Assesses industy compliance with and tracks of all regulatory requirements of FDA legislation including FDAAA.
Provides authoritative advice, counsel, or instruction to employees on both regulatory work and administrative matters.
Plans work to be performed by subordinates members, sets and adjusts both short-term and long-term priorities, and prepares schedules for completion of work.
Interviews candidates for positions in the Division and recommends the appointment, promotion, or reassignment to such positions.
Evaluates work performance of subordinates.