What do Regulatory Health Project Managers do at CDER?

The duties of a Regulatory Health Project Manager at CDER differ by office. Opportunities may include:

• Providing technical advice and consultation for Center-wide programs and workgroups associated with drug quality application review and facility inspections.
• Managing/co-leading multidisciplinary drug review teams across CDER in the review of clinical, scientific, quality, regulatory, and other data submitted in support of an assigned class of drug/biological products across the product lifecycle.
• Driving completion of work products and program deliverables by performing triage, creating project plans, communicating progress, managing deadlines, and achieving milestones.
• Ensuring that all goals, deadlines, metrics specified in user fee acts, laws/ statutes, and regulations are met for assigned projects.
• Serving as the liaison for all communications with stakeholders engaged or interested in the FDA drug review process. May involve collecting technical information, explaining current regulatory requirements, and facilitating technical information-gathering meetings.

Related positions include:

• Consumer Safety Officer

How can I find a Regulatory Health Project Manager position at CDER?

Available CDER positions are listed on USAJOBS and under the FDA 21st Century Cures Act Hiring Authority.

1. Search USAJOBS by Keyword: CDER. You can filter your search by Agency: Food and Drug Administration and Series: 0601 - General Health Science or 0696 - Consumer Safety.
2. See CDER’s listing of employment opportunities utilizing the FDA 21st Century Cures Act Hiring Authority: We Are Hiring | FDA.

Where can I learn more about careers at the FDA?

For general information on working at the FDA and additional employment opportunities, visit: Jobs and Training at FDA.