Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Manager, Global Regulatory Strategy based in the United States.
In this strategic and highly cross-functional role, you will help shape and execute global regulatory strategies that support both development-stage and marketed pharmaceutical products. You will contribute to advancing innovative therapies across oncology and rare diseases, ensuring alignment between regulatory pathways and broader clinical, CMC, and commercial objectives. Working closely with senior regulatory leadership, you will help prepare and support health authority interactions across multiple regions, including FDA, EMA, TGA, PMDA, and CDE. This role plays a key part in translating complex regulatory frameworks into actionable development plans that enable timely approvals and successful product lifecycles. You will operate in a fast-paced, global environment, collaborating with diverse stakeholders across R&D, quality, and commercial teams. The position is ideal for a regulatory professional passionate about precision medicine and improving outcomes for patients with high unmet medical needs.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Manager, Global Regulatory Strategy based in the United States.
In this strategic and highly cross-functional role, you will help shape and execute global regulatory strategies that support both development-stage and marketed pharmaceutical products. You will contribute to advancing innovative therapies across oncology and rare diseases, ensuring alignment between regulatory pathways and broader clinical, CMC, and commercial objectives. Working closely with senior regulatory leadership, you will help prepare and support health authority interactions across multiple regions, including FDA, EMA, TGA, PMDA, and CDE. This role plays a key part in translating complex regulatory frameworks into actionable development plans that enable timely approvals and successful product lifecycles. You will operate in a fast-paced, global environment, collaborating with diverse stakeholders across R&D, quality, and commercial teams. The position is ideal for a regulatory professional passionate about precision medicine and improving outcomes for patients with high unmet medical needs.