Vacant job

Job Description

Senior Specialist, Regulatory Drug Project Delivery is a pivotal operational and strategic role within the Global Regulatory Affairs department.

The primary mission of this role is to lead and project-manage the end-to-end delivery of regulatory submissions (such as clinical trial applications, marketing authorizations, and variations) to health authorities globally (e.g., FDA, EMA, MPA) to get life-changing medicines to patients.

This is a consulting assignment with Randstad Life Sciences. Randstad Life Sciences specializes in competencies within Life Science. As a consultant with us, you receive a competitive salary, benefits, and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities

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.

Qualifications

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.

About the company

Randstad

At Randstad, we know that everyone has a place in the labor market. With operations across the country and within all competency areas, we help people find a job that feels right, where they have the opportunity to grow, develop, and reach their full potential. With nearly 600,000 employees in 38 countries, Randstad is the world leader in HR services, with the goal of becoming the world's best and most appreciated partner in the labor market. By combining our passion for people with the power of today's technology, we help people and companies achieve their full potential. We call it Human Forward.