Sr. Manager/Associate Director, Regulatory Writer

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Sr. Manager/Associate Director, Regulatory Writer based in the United States.

We are seeking an experienced regulatory writing professional to lead the development and delivery of high-quality scientific and regulatory documentation across global clinical development programs.

In this remote role, you will oversee document strategy, author complex regulatory submissions, and coordinate cross-functional contributors to support programs from initial clinical development through marketing applications and lifecycle management.

You will partner with experts across Regulatory Affairs, Clinical Development, Biometrics, Safety, Nonclinical, and Chemistry, Manufacturing, and Controls (CMC) to ensure scientific accuracy and regulatory compliance. As the primary writing lead for major submissions and health authority interactions, you will establish best practices, strengthen document quality, and maintain submission readiness.

You will also mentor writers, manage external vendors, and improve processes that support efficient, consistent document delivery. This is an opportunity to influence global development strategies and contribute to advancing innovative therapies for patients with significant unmet medical needs.