(Senior) Regulatory Affairs Specialist - Japan- Home-based

Requisition Number: 5718

Position Title: Specialist, Regulatory Affairs

External Description:

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 2,500 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

• Liaise with colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis. Where required provide local QC of submission dossiers prior to dispatch
• May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
• Effectively communicate to the Lead and relevant project team members the status and action plans concerning submissions and advise the project team about appropriate regulatory strategies
• Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements

 

What you will bring to the role

 

• Strong organizational and management skills
• Self-motivated learning about current regulatory processes and intelligence
• Excellent written and verbal communication skills to clearly and concisely present information
• Team-oriented work style; seeks and gives guidance to others
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Excellent ability to handle multiple tasks in a fast-paced and changing environment

 

Your background

 

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
• Minimum one year of experience in clinical research, in regulatory-related function
• Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance
• Multilingualism preferred; fluent in local language; working knowledge of English

 

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.   

 

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

 

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Employment Type: Regular

Community / Marketing Title: (Senior) Regulatory Affairs Specialist - Japan- Home-based

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Tokyo, JP

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