senior specialist, regulatory drug project delivery

You are essentially the "controller" and operational execution lead for a drug project’s regulatory journey. While the Regulatory Director focuses on the long-term scientific and political strategy with health authorities, the Senior Specialist focuses on how that strategy gets built, managed, and successfully submitted.

You work in a matrix environment, bridging the gap between scientists, clinical teams, medical writers, and publishing teams.

In this role, you will experience the full drug development pipeline through three high-impact rotations within Respiratory & Immunology:

• Rotation 1: Genome Engineering (Early Discovery) Focus on cutting-edge biotechnology by conducting independent research on novel gene-editing projects. In this lab-based role, you will execute experimental protocols, analyze complex data sets, and collaborate with senior scientists to support high-profile scientific publications.

• Rotation 2: Early Clinical Development Shift from the lab bench to clinical trials by supporting the design and execution of a Phase 2 trial for Crohn’s disease. You will partner with Clinical Scientists and Study Physicians on medical monitoring, data review, and protocol amendments. You will also manage site communications (including urgent medical queries) and author key pediatric strategy documents and investigator meeting materials.

• Rotation 3: Patient Centered Science Bridge the gap between clinical data and the human experience by researching patients’ lived experiences to develop and validate Patient-Reported Outcome (PRO) measures.