Specialist, Regulatory Affairs

hace 2 semanas

Madrid, España Worldwide Clinical Trials A tiempo completo
Requisition Number7568Employment Type:Regular

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. 

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. 

What you will do

You will be a subject matter expert and local point of contact for activities supporting Regulatory submissions, site activation and maintenance for awarded projects. You will be responsible for planning, initiating and tracking documents required for regulatory submissions, essential documents collection, review and provision of country/site/EC requirements to support achievement of site activation goals and communicating status, risks and actions related to any start-up activities and maintenance when applicable.

What you will bring to the role

Strong organizational and management skills. Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills. Self-motivated learning about current regulatory processes and intelligence Proactive by identifying potential issues in the process and anticipating solutions Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel Easily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and quality Team-oriented work style; seeks and gives guidance to others

Your experience

Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science Minimum two year of experience in clinical research, in site activation and/or regulatory-related function within a CRO Candidates must have experience of the regulatory process in South Korea to be considered for this role. Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations Multilingualism preferred; fluent in local language; working knowledge of English

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