Regulatory Affairs Coordinator - Part-time

WHO ARE WE?

At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 53,000 employees globally who nurture a diverse, collaborative, and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

 

THE OPPORTUNITY

 

As the Regulatory Affairs Coordinator (part-time) you will be supporting practical and administrative handling of packaging material in order to ensure the timely implementation on the market of approved patient leaflet and labelling of products for human use.

Besides, you will support the Regulatory Affairs department in the overall responsibilities for timely submission of applications and regulatory compliance of the OPU’s product portfolio. You will adjust to regulatory requirements to sustain continuous market supply and patient safety.

This position is based in Amsterdam and reports directly to the Head of Regulatory Affairs.  Please note that this is a part-time position and external 1 year contract is being offered.

 

YOUR KEY RESPONSIBILITIES

 

• Perform proofreading of packaging texts following established corporate and internal procedures.
• Archiving of regulatory correspondence in the document management system.
• General administrative support tasks (e.g. planning of meetings & agenda, translating documents to English for nationally registered products, etc.)
• Support in the creation of documentation needed for variation or notification.
• Support the implementation of any change on the existing packaging material, as well as the launch of new packaging material.
• Handle requests for Certificate of a Pharmaceutical Product (CPP).
• Be compliant with daily Regulatory Affairs tasks in the local RA organization.

 

WHAT YOU SHOULD BRING TO THE TEAM

 

• Associate or Bachelor’s degree in Medicine/Pharmacology/Lifesciences, or relevant working experience.
• Experience in the pharmaceutical industry is preferred.
• Knowledge of regulations within the pharmaceutical industry – preferred.
• Practical experience with MS Office.
• Excellent command of the Dutch & English languages.
• Able to stick to timelines and manage multiple tasks at the same time.
• Systematic, organized, and strong administrative capacity.
• Curiosity, innovative thinking and eager to learn new things.
• Flexible and willing to work in a fast-paced and diverse environment.

 

WHAT WILL YOU GET IN RETURN?

 

Next to working in a Gl