Job description
The Regulatory Affairs Labeling Director will serve as an expert resource for regulatory labeling and will lead the successful development and implementation of labeling for the company.
Location – Remote:
Essential Duties And Responsibilities
Location – Remote:
Essential Duties And Responsibilities
- Create and maintain labeling content for marketed product(s) and development products in US and international regions including: CCDS, prescribing information, medication guides, patient information, package label artwork
- Liaise with external partners or distributors in international markets, as applicable
- Conduct research on competitor and other relevant labeling precedents to support high quality, commercially viable labels
- Develop project timelines and manage labeling projects from initiation to completion
- Lead Core Label Working group meetings
- Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork)
- Help develop, review, and approve global package artwork in close collaboration with Supply Chain, Quality Assurance, and external partners
- Education: Bachelor’s Degree in life sciences minimum
- 9+ years of related experience within regulatory affairs with a bachelor’s degree; or 7+ years of related experience within regulatory affairs with a master’s degree; or a PhD with 4+ years’ of related experience within regulatory affairs with; or equivalent experience
- Experience representing Regulatory Affairs Labeling on cross functional teams
- Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others
- Experience in interpreting regulations, guidelines, and policy statements relevant to labeling
- Comprehensive knowledge of labeling regulations in the U.S. and EU
- Strong interpersonal communication skills