Senior Regulatory Consultant

Avania•,

11d•$150,000 - $150,000

About The Position

Avania is looking for a Senior Regulatory Consultant to strengthen our expertise in drug, biologic, and combination-product regulation. This role will support projects adjacent to our core medical device work, including biologic tissue products, drug-delivery devices, and other products that require clinical trials but do not fit neatly within a traditional medical device or pharmaceutical model. You will serve as an individual contributor and work closely with internal regulatory experts to help Avania pursue and deliver this growing area of client work. The ideal candidate brings strong pharmaceutical or biologics regulatory experience and is interested in expanding their knowledge of the medical device landscape.

Requirements

Strong pharmaceutical or biologics regulatory experience
Interest in expanding knowledge of the medical device landscape

Responsibilities

Provide regulatory expertise for US and EU drug, biologic, drug-delivery device, and combination-product projects.
Support regulatory strategy and submissions for products that sit at the intersection of pharmaceuticals, biologics, and medical devices.
Contribute knowledge of clinical trial submission processes for drugs and biologics.
Work with internal subject-matter experts to translate complex regulatory requirements into practical guidance and project delivery.
Partner with colleagues across Avania’s advisory and CRO functions to support existing projects and help build capability in adjacent life-sciences markets.
Apply your pharmaceutical or biologics experience while developing deeper familiarity with medical device regulations and submissions.