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What is the RPM in regulatory affairs?

The RPM plays a crucial role in guiding and advancing projects by translating global regulatory strategy into actionable plans at the asset level. This individual acts as a regulatory project management expert, ensuring alignment and coordination among cross-functional teams to drive successful outcomes.

What is the role of the RPM in the FDA?

The FDA RPM: The review division regulatory project manager (RPM) is the primary point of contact for communications between IND sponsors and FDA during the life cycle of drug development, and has comprehensive knowledge of the drug and its regulatory history.

What is the main purpose of the Food and Drug Administration?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.

What is FDA commissioning?

FDAs Commissioning Program FDA is authorized to conduct examinations and investigations for the purposes of the Food, Drug, and Cosmetic (FDC) Act through health, food, or drug officers or employees of state and local governments who are commissioned by FDA as an officer of FDA.

What is a regulatory project manager in FDA?

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.

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