Associate Director, Global Regulatory Labeling, Policy and Intelligence at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Global Regulatory Labeling, Policy and Intelligence in United States.

This role plays a critical part in shaping and maintaining global regulatory labeling strategy across a complex biopharmaceutical portfolio. You will lead cross-functional labeling activities spanning key global documents such as CCDS, USPI, and SmPC, ensuring alignment with regulatory requirements and product strategy. Operating within a highly scientific and fast-evolving environment, you will serve as a subject matter expert influencing global labeling decisions and regulatory direction. The position also extends into regulatory policy and intelligence, providing insights into evolving global guidelines and their business impact. You will collaborate closely with global regulatory, clinical, and medical teams to ensure consistency, compliance, and strategic optimization of labeling content. This is a high-impact role where precision, leadership, and regulatory expertise directly support innovative therapies that improve patient outcomes worldwide.

Lead the development, maintenance, and strategic oversight of global labeling documents, ensuring compliance, consistency, and alignment with regulatory and product development strategies across regions.

• Chair and lead the Labeling Working Group to manage CCDS, USPI, SmPC, Core Safety Information, and related patient labeling documents.
• Act as global labeling subject matter expert, advising on labeling strategy based on clinical data, regulatory requirements, and competitive landscape.
• Oversee the preparation, review, submission, and lifecycle management of labeling documents in accordance with global regulatory standards and internal SOPs.
• Monitor global regulatory guidelines and labeling trends, translating insights into actionable recommendations for internal stakeholders.
• Collaborate with global and regional regulatory leads, clinical teams, and cross-functional partners to ensure labeling alignment and execution.
• Manage complex labeling projects, including those involving external partners and multi-region coordination.
• Contribute to the development and improvement of internal processes, SOPs, and systems supporting labeling operations and compliance.

Bachelor’s degree in a scientific discipline is required; advanced degree such as PharmD or PhD preferred.

• 3–5+ years of pharmaceutical or biotechnology industry experience, including strong exposure to regulatory labeling or related functions.
• Deep understanding of US and global regulatory frameworks governing labeling, including FDA and EMA requirements.
• Experience supporting or leading labeling activities for major submissions such as NDA or BLA preferred.
• Strong ability to interpret regulatory intelligence, distinguish critical insights, and translate them into strategic recommendations.
• Excellent communication skills with the ability to influence cross-functional and senior stakeholders in a global environment.
• Strong organizational skills with the ability to manage multiple complex priorities in a fast-paced setting.
• Experience in biologics, oncology, or other complex therapeutic areas is highly desirable.
• Proficiency with MS Office tools and document management systems; familiarity with global labeling processes end-to-end.

• Competitive compensation package aligned with experience and expertise level
• Annual performance-based bonus and potential long-term incentives
• Comprehensive health coverage including medical, dental, and vision plans
• Retirement savings plan with employer matching
• Generous paid time off, holidays, and parental leave programs
• Flexible working environment supporting remote and hybrid arrangements
• Strong focus on employee wellbeing, including mental health and family support resources
• Professional development opportunities in a global, science-driven organization
• Additional benefits such as wellness support, commuter programs, and learning resources