Opus Regulatory Inc. ยท 2 weeks ago
Principal Consultant, Regulatory Affairs Labeling
United States
Full-time
Remote
Senior Level, Lead/Staff
4+ years expOpus Regulatory, Inc. is a niche firm providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. The Principal Consultant, Regulatory Affairs Labeling is responsible for managing regulatory requirements for labeling strategy and operations, leading projects, and developing relationships with clients and regulatory authorities.
AdvertisingConsultingPharmaceutical
Responsibilities
Labeling experience across Development, Core, US, EU and Rest of World (ROW) Labeling
Understanding of end-to-end labeling process and systems
Lead preparation, review, and update content for the development and maintenance of Target Product Label (TPL), Company Core Data Sheet (CCDS), and local labeling and labeling components
Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory labeling, 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 by evaluating and communicating risks associated with CCDS content updates and implementation strategies
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 labeling timelines and deliverables
Understanding of labeling governance and process work
Support agency requests and documentation process for impact to labeling; participate in agency meetings as requested
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
Required
4 to 7+ years pharmaceutical regulatory affairs experience within Labeling
Bachelor's degree
Experience within many different therapeutic areas as well as labeling operations
Global and International experience
Proven project management skills to support the planning and coordination of labeling submissions and support appropriate regulatory inspections
Ability to work independently and to be innovative in tackling operational challenges
Preferred
advanced degree in a science discipline
Company
Opus Regulatory Inc.
Opus Regulatory is a niche Regulatory Affairs consulting firm providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Dave Sawyer
CEO/Founder
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