Senior Manager, Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Regulatory Affairs based in United States.

This is a strategic regulatory leadership role supporting the development and registration of innovative oncology products across the United States and international markets. You will manage complex regulatory projects spanning clinical, non-clinical, and CMC activities. The role offers the opportunity to shape submission strategies and accelerate regulatory pathways from development through approval. You will work closely with cross-functional teams and provide expert regulatory guidance throughout the product lifecycle. The position combines hands-on submission management, strategic planning, regulatory intelligence, and technical writing. Success requires strong judgment, organization, communication, and the ability to operate independently in a fast-paced environment. This is an impactful opportunity to contribute to bringing potentially life-changing medicines to patients more efficiently.