Associate Director / Director, Regulatory Affairs

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

This role sits at the core of advancing innovative therapies for genetic diseases, with responsibility for shaping and executing regulatory strategies across early clinical development programs. You will operate in a highly dynamic biotech environment where science, clinical development, and regulatory execution intersect. The position requires a strategic mindset paired with strong hands-on capability to guide programs through complex global regulatory pathways, including rare disease and expedited development frameworks. You will partner closely with cross-functional teams such as Clinical Development, CMC, Translational Sciences, and Nonclinical to ensure regulatory alignment at every stage of development. A key part of the role involves direct engagement with global health authorities and ownership of high-quality regulatory submissions. This is a high-impact opportunity to help bring transformative genetic disease therapies closer to patients while working in a fast-paced, science-driven environment.

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

This role sits at the core of advancing innovative therapies for genetic diseases, with responsibility for shaping and executing regulatory strategies across early clinical development programs. You will operate in a highly dynamic biotech environment where science, clinical development, and regulatory execution intersect. The position requires a strategic mindset paired with strong hands-on capability to guide programs through complex global regulatory pathways, including rare disease and expedited development frameworks. You will partner closely with cross-functional teams such as Clinical Development, CMC, Translational Sciences, and Nonclinical to ensure regulatory alignment at every stage of development. A key part of the role involves direct engagement with global health authorities and ownership of high-quality regulatory submissions. This is a high-impact opportunity to help bring transformative genetic disease therapies closer to patients while working in a fast-paced, science-driven environment.

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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