Regulatory Affairs Labeling Director

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Requirements:

• 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
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.

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
• Perform other duties and responsibilities as assigned