Mirum develops patient-inspired therapies for rare disease, advancing medicines where unmet need is greatest. Mirum is relentlessly rare. Learn more. Backed by NEA.
About the role
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.
What they're looking for
- Bachelors or advanced degree in a scientific discipline, with a minimum of 3-6 years of regulatory labeling experience in the biopharmaceutical industry
- Experience with writing, developing, maintaining product labeling in the US and EU, experience around the globe is desirable including LATAM, Middle East, and Asia-Pacific
- Experience representing Regulatory Affairs Labeling on cross functional teams
- Excellent verbal, written, negotiation, influence and interpersonal communication skills are required
- Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others. Must be self-directed
- Experience leading a team to project completion on deadline
More about this role
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.
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.
- Create and update labeling content for assigned programs of marketed product(s) and development products in US and international regions including: CCDS, prescribing information,...
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