Aleese Hopkins Email & Phone Number | • Provides project management and submission support for original applications and life cycle management, including PINDs, INDs, Orphan Drug Designations, and amendments. • Serves as a U.S. Agent Representative for foreign groups as well as a primary regulatory contact for U.S. based companies. This includes facilitating communication between FDA and the sponsor as well as ensuring requirements and timelines are met. • Coordinate and participate in FDA meetings, including preparing and debriefing sessions. • Experience in eCTD formatting and trained in electronic publishing. Able to advise Sponsors regarding best practices to implement during the writing process in order to support compliant electronic submissions of their application. • Experience in formatting, quality control, and technical writing. • Trained in quality assurance.

Aleese Hopkins

• Provides project management and submission support for original applications and life cycle manage...
Raleigh, North Carolina, United States

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Aleese Hopkins’s Location Raleigh, North Carolina, United States

Aleese Hopkins’s Current Industry Biologics Consulting

Aleese Hopkins’s Prior Industry Aclairo Pharmaceutical Development

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Regulatory Affairs Manager

2024-01-01 00:00:00 - Present

Research and QA Associate

2014-06-01 00:00:00 - 2017-09-01 00:00:00

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Aleese Hopkins is a • Provides project management and submission support for original applications and life cycle management, including PINDs, INDs, Orphan Drug Designations, and amendments. • Serves as a U.S. Agent Representative for foreign groups as well as a primary regulatory contact for U.S. based companies. This includes facilitating communication between FDA and the sponsor as well as ensuring requirements and timelines are met. • Coordinate and participate in FDA meetings, including preparing and debriefing sessions. • Experience in eCTD formatting and trained in electronic publishing. Able to advise Sponsors regarding best practices to implement during the writing process in order to support compliant electronic submissions of their application. • Experience in formatting, quality control, and technical writing. • Trained in quality assurance.