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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 a 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 Global Top Employer certified company that offers you the opportunity to develop and challenge yourself while learning from a fast-paced environment: 

  • Be part of a wellbeing-oriented organization (Premium access to Headspace and ongoing support and initiatives related to ways of working to help our employees to stay healthy and constantly improve the physical, emotional, mental, and spiritual well-being) 
  • A competitive salary range based on seniority and skills and 31 vacation days to re-energize 
  • Customized Development plan based on your role and aspirations, with several learning platforms such as LinkedIn Learning Premium (languages + training programs) and our Virtual Campus Lifelong learning at our Virtual Campus | Boehringer Ingelheim (boehringer-ingelheim.com) 
  • Green mobility package where you get compensated even for cycling to the office – which is an inspiring, sustainable (platinum-certified) building  
  • Hybrid workplace model – flexibility to work from home within the respective country and our sustainable (platinum-certified) office  
  • A diverse team that enjoys fun activities and celebrations (e.g., Team events, Christmas Party) and values a respectful working atmosphere! 

 

WHAT’S NEXT?

We are looking forward to receiving your application! We will then have a look at your CV and cover letter. If we see a match, we will invite you for a video call or a face-to-face interview.

The application deadline is March 8th.

 

DIVERSITY & INCLUSION

At Boehringer Ingelheim we share the opinion that diversity and inclusion is essential for the growth of our business and that our strengths and competitive advantage are also the result of the diversity of our company – diversity across the three dimensions of inclusion: Gender, Geography and Generation. Our people are part of a deep-rooted, family company philosophy that welcomes everyone! We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin. 

 

Screening:

In order to comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (“SPL”). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.

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