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.

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, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork.

• Conduct research on competitors and other relevant labeling precedents to support high quality, commercially valid labels for Mirum products.

• Develop project timelines and manage labeling projects from initiation to completion.

• Represent Regulatory Affairs at labeling meetings and provide strategic regulatory guidance, as appropriate.

• Leadership role in Label Working Group and internal review and approval process of labeling documents.

• Ensure labeling is compliant with local country regulations and guidances. This can be accomplished by managing and utilizing local resources (e.g., in-country or in-region labeling consulting services)

• Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork).

• Liaise with external partners or distributors in international markets, as applicable.

• Support International Regulatory Affairs colleagues when responding to local health authority queries about product labeling.

• Act as primary contact for translation vendors in development of labeling documents in foreign languages.

• Represent Global Regulatory Affairs on the Global Artwork Team; help develop, review and approve global package artwork in close collaboration with Supply Chain and Quality Assurance and International Regulatory Affairs colleagues.

• Coordinate with multidisciplinary team for implementation of commercial labeling updates.

• Serve as an expert resource for regulatory labeling advice across departments.

• Maintain a continued awareness and understanding of FDA, EU, and international health authority regulations, guidance documents with regards to product labeling for pharmaceutical products; assess impact of new regulations on Mirum products.

• Manage labeling archive and internal trackers.

• Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency.

• 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