Associate Director, Global Regulatory Affairs Labeling

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

This role is a key global regulatory leadership position focused on shaping, developing, and maintaining labeling strategy across the lifecycle of innovative rare disease therapies. It plays a critical part in ensuring that product labeling is scientifically accurate, globally aligned, and fully compliant with evolving regulatory requirements across major markets. The position operates at the intersection of regulatory affairs, clinical development, safety, and commercial functions, translating complex regulatory inputs into clear, actionable labeling strategies. It also supports the development of core labeling documents and ensures consistency across global submissions and product lifecycle updates. The environment is highly cross-functional and matrixed, requiring strong collaboration with internal stakeholders and external partners. It is an ideal role for a regulatory expert who thrives in fast-paced, science-driven environments with global impact.