Note: The job is a remote job and is open to candidates in USA. Opus Regulatory Inc. has provided strategic guidance to industry partners for over 30 years, specializing in regulatory affairs. The Principal Consultant, Regulatory Affairs Labeling Strategy will manage regulatory requirements for labeling strategy, lead the preparation and review of labeling content, and provide expertise to client regulatory teams.
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
Skills
- Must have a minimum of 4 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy
- Bachelor's degree required
- Experience across multiple therapeutic areas is highly desirable
- Demonstrated global and international experience is required
- Proven project management skills to support the planning and coordination of labeling submissions and support appropriate regulatory inspections
- Ability to work independently and innovatively in tackling operational challenges
- Advanced degree in a science discipline
Benefits
- Medical, dental, vision, and prescription drug coverage for employees and their eligible family members
- Life Insurance
- Short-Term Disability (STD)
- Employee Assistance Program (EAP)
- 401(k) plan
- Paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually
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