Opus Regulatory Inc. · 6 hours ago

Principal Consultant, Regulatory Affairs Labeling

United States

Full-time

Remote

Mid, Senior Level, Lead/Staff

4+ years exp

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Responsibilities

Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with client leadership.

Provide support and guidance to regulatory teams on RA requirements for one or more drug products.

Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.

Develop and drive regulatory timelines; lead submission activities for one or more drug development stages.

Review and maintain regulatory submission documentation.

Manage agency requests and documentation process; participate in agency meetings.

Maintain knowledge of changing regulatory requirements and advise teams as appropriate.

Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.

Qualification

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Regulatory AffairsProject ManagementTherapeutic Areas ExperienceGlobal ExperienceAdvanced Degree in ScienceInnovative Problem Solving