Opus Regulatory Inc. · 3 hours ago

Principal Consultant, Regulatory Affairs Labeling

United States

Full-time

Remote

Mid, Senior Level, Lead/Staff

4+ years exp

Maximize your interview chances

AdvertisingConsulting

Insider Connection @Opus Regulatory Inc.

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory AffairsProject ManagementTherapeutic Areas ExperienceGlobal ExperienceAdvanced Degree in ScienceInnovative Problem Solving