Associate Director, Clinical Regulatory Writing – Hybrid

AstraZeneca is seeking an Associate Director/Manager in Clinical Regulatory Writing in Gaithersburg, MD, with a hybrid work arrangement (3 days onsite). The role leads complex regulatory writing efforts across drug projects, ensuring regulatory and quality standards.

You will set submission strategies, guide teams, and partner with vendors to deliver high-quality documents. The position requires strong leadership, deep regulatory writing knowledge, and the ability to translate data into clear