A company is looking for a Director, Global Regulatory Labeling Strategy.
Key Responsibilities
Lead cross-functional teams to align labeling strategy and content
Independently author and manage labeling documents and oversee submission processes
Manage local labeling exceptions and provide support to local affiliates regarding health authority requests
Required Qualifications
BSc degree preferred; advanced scientific degree (MSc, PhD, or PharmD) preferred
10+ years of pharmaceutical industry experience, including 8 years of labeling experience
In-depth expertise of US and EU product labeling requirements and regulations
Strong project management skills and ability to lead cross-functional teams
Ability to develop and execute regulatory strategies in alignment with business objectives
Director Of Strategy • Paterson, New Jersey, United States