Remote Regulatory Affairs Labeling Director
SpringWorks Therapeutics
💵 $167k-$220k
📍Remote - United States
Please let SpringWorks Therapeutics know you found this job on JobsCollider. Thanks! 🙏
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
Share this job:
Disclaimer: Please check that the job is real before you apply. Applying might take you to another website that we don't own. Please be aware that any actions taken during the application process are solely your responsibility, and we bear no responsibility for any outcomes.
Similar Remote Jobs
- 📍United States
- 💰$160k-$180k📍United States
- 💰$238k-$252k📍United States
- 📍United States
Manager II, Medical Legal Regulatory Review
Tarsus Pharmaceuticals, Inc.
💰$107k-$150k📍United States- 📍United States
- 💰$170k-$219k📍United States
- 💰$229k-$283k📍United States
Please let SpringWorks Therapeutics know you found this job on JobsCollider. Thanks! 🙏