Director, Global Regulatory Affairs Labeling

Mirum Pharmaceuticals - Foster City, CA

Full-time - Senior

Foster City, CA

Chemical Manufacturing

About the position

The Director, Regulatory Affairs Global 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 Director will partner with all Regulatory Affairs functions, Medical Affairs, Legal, Clinical Development, Commercial and International distributors and will lead the Label Working Group. This role will report to the SVP, Global Regulatory Affairs.

Responsibilities

• Create and maintain 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.
• Lead the Label Working Group (LWG) and internal review and approval process of labeling documents.
• 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 to support 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.
• Ensure labeling is compliant with local country regulations and guidance.
• 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.
• 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, Quality Assurance, and International Regulatory Affairs colleagues.
• Serve as an expert resource for regulatory labeling advice across departments.
• Maintain a continued awareness and understanding of FDA, EMA, 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.

Requirements

• Bachelor's or advanced degree in a scientific discipline.
• Minimum of 12 years in Regulatory Affairs.
• Minimum of 8-10 years of regulatory labeling experience in the biopharmaceutical industry.
• Experience with writing, developing, maintaining product labeling in the US and EU is required.
• Experience representing Regulatory Affairs Labeling on cross functional teams.

Nice-to-haves

• Experience with global rules and regulations regarding labeling of medical products.
• Experience with US FDA and international Health Authorities.
• Experience with using Veeva Vault RIM and QualityDocs.