Remote Regulatory Affairs Labeling Director
SpringWorks Therapeutics
💵 $167k-$220k
📍Remote - United States
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Job highlights
Summary
Join a dynamic team at SpringWorks Therapeutics as the Regulatory Affairs Labeling Director, leading the development and implementation of labeling for products in US and international regions.
Requirements
- Education: Bachelor’s Degree in life sciences or related science degree; Advanced degree preferred
- 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
- Oncology, rare disease, and/or other relevant therapeutic area experience is desirable
- 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 Europe
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/leaflet/IFU, 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 and provide strategic regulatory guidance, as appropriate
- Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork)
- Support International Regulatory Affairs colleagues when responding to local health authority queries regarding product labeling
- Help develop, review, and approve global package artwork in close collaboration with Supply Chain, Quality Assurance, and external partners
Benefits
- Health insurance
- Retirement benefits
- Paid time off
- Remote work, flexible hours
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