Specialist, Regulatory Affairs - German speaker - Europe -Remote

Job Overview

Worldwide Clinical Trials is seeking a Specialist, Regulatory Affairs - German speaker - Europe - Remote to join their team.

About Us

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 over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Regulatory Affairs Department

Regulatory Affairs is pivotal in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations.

Job Responsibilities

• Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis
• Act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
• Provide local QC of submission dossiers prior to dispatch
• Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions
• Identify risks and generate mitigation strategies
• Foster professional working relationships with internal and external contacts to ensure expeditious submission / approval of regulatory dossiers
• Maintain country specific patient information sheet and consent form customization text
• Maintain country specific drug labeling information
• Maintain Country Intelligence Pages
• Be familiar with and comply with SOPs, ICH GCP and applicable regulations
• Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database
• Advise the SAR 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
• Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department

Requirements

What We Offer

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.

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