Sanofi
Healthcare
GlobalLabelingStrategist
“Global Labeling Strategist at Sanofi. Skills: Labeling strategy, Regulatory affairs, Clinical development input. Lead preparation of global labeling strategy. Lead review of global labeling strategy”
Industry & Context.
What They're Looking For.
Must Have
Bachelor's degree in life sciences, pharmacy, or medically related field, Minimum 8+ years pharmaceutical industry experience, At least 4 years in regulatory affairs or labeling, Experience supporting labeling strategy in developmental and/or marketed products, Familiarity with clinical protocol development, Familiarity with regulatory labeling expectations
Nice to Have
Advanced degree (PharmD, PhD, MD or MSc) preferred, Exposure to patient experience data is advantageous
What You'll Do.
Lead preparation of global labeling strategy
Lead review of global labeling strategy
Lead maintenance of global labeling strategy
Provide labeling input for clinical study protocols
Contribute to discussions on clinical endpoint selection
Contribute to integration of patient experience data
Assist in labeling submissions
Assist with regulatory queries
Assist with updates to ensure compliance
Support alignment between global and regional labeling
Participate in cross-functional regulatory teams
Participate in labeling governance processes
Stay informed of regulatory guidelines
Stay informed of industry trends
Stay informed of competitor labeling activities
Provide mentoring to junior strategists
Provide training to junior strategists
Support process improvements within labeling function
How You'll Work.
Team & Collaboration
Cross-functional teams; Global Regulatory Affairs; Clinical Development; Safety; Medical Affairs; Cross-functional regulatory teams; Labeling governance processes
Communication Scope
Collaborative communication
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