Senior Manager, Regulatory Affairs Labeling
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The Senior Manager (SM), Regulatory Affairs Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed products. The SM/AD will have the opportunity to partner with all Regulatory Affairs functions, Medical Affairs, Legal, Clinical Development, Commercial and International distributors and will play a lead role on the Label Working Group. This role will report to the Senior Director, Global Commercial Regulatory Affairs & Labeling.
JOB FUNCTIONS/RESPONSIBILITIES
- Create and update labeling content for assigned programs of marketed product(s) and development products in US and international regions including: CCDS, prescr
