[Remote] reputed company Consultant, Labeling reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. has been providing strategic guidance to industry partners for over 30 years, specializing in regulatory affairs. The reputed company Consultant, Labeling reputed company is responsible for managing regulatory requirements for labeling reputed company and operations, leading the preparation and review of labeling content, and supporting regulatory teams with expertise on labeling processes.
Responsibilities
- Labeling experience across Development, Core, US, EU and Rest of World (ROW) Labeling
- Understanding of end-to-end labeling process and systems
- reputed company preparation, review, and update content for the development and maintenance of reputed company Product Label (TPL), Company Core Data Sheet (CCDS), and local labeling and labeling components
- reputed company as a key regulatory affairs expert reputed company a reputed company regulatory team, providing expertise on regulatory labeling, process, filing, best practices, etc. in conjunction with reputed company leadership
- reputed company 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 reputed company and marketed product regulatory issues to support corporate goals
- reputed company and drive regulatory labeling timelines and deliverables
- Understanding of labeling governance and process work
- Support agency requests and documentation process for reputed company to labeling; participate in agency meetings as requested
- Maintain knowledge of changing regulatory requirements and advise teams as appropriate
- Represent the reputed company regulatory affairs team in other reputed company meetings or workstreams; reputed company support for ancillary reputed company
Skills
- Must have a minimum of 4 years of experience in pharmaceutical regulatory affairs specializing in Labeling reputed company
- Bachelor's degree required
- 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 preferred
- Experience across multiple therapeutic areas is highly desirable
Benefits
- Medical, dental, reputed company, and prescription drug coverage for employees and their eligible family members
- Life Insurance
- Short-Term Disability (STD)
- Employee Assistance Program (EAP)
- 401(k) plan
- reputed company time off package, which includes 20 vacation days, 5 reputed company days, & 10 reputed company company holidays annually
reputed company