Regulatory Affairs Specialist

Regulatory Affairs Specialist | 1044977 | Utrecht | Bachelor+ | CMC | remote | chemical | pharma
Your new role
As a Regulatory Affairs Specialist your main responsibility will be to prepare, submit, maintain and expand product registrations in different countries and to keep the companies’ products in compliance with all regulatory needs. Your tasks will include:
  • Consolidation of the Chemical/Pharmaceutical part of the dossier;
  • Collaborate with your colleagues from the quality department on CMC questions;
  • Organizing submission of Marketing Authorisation variations and renewal/re-registration applications for the EU;
  • Coordinating with the National Competent Authorities (NCA) and relevant colleagues / partners during the application evaluation process to ensure, prepare and submit timely responses to Authorities comments and questions;
  • Preparing and regularly checking Quality Product Compliance Summaries for pharmaceutical products;
  • Archiving registration documentation.

Your profile
In order to be successful as a Regulatory Affairs Specialist, you have at least a Bachelor’s degree in chemistry, chemical engineering, medicine, pharmaceutics biochemistry or a similar field.
You combine this background with at least 2 years of experience in Regulatory Affairs in a pharmaceutical company. You have CMC experience, dossier content knowledge and quality and production knowledge. You are fluent in English, Dutch is not mandatory for this position.
As a person you are detail oriented and easy going, you also know how to prioritize when time is tight.

About the organization
You will be working for a global specialist in veterinary pharmaceuticals that has been active for over 200 years already. They are experts in the development, manufacturing, marketing and sales of high quality products exclusively for veterinarians worldwide. They have almost 6000 product registrations and distribute to almost 70 countries. Their headquarters are in the UK and they have locations in 25 countries and 7 manufacturing sites. You will be part of their team of almost 2000 colleagues globally. In the Netherlands, they have 3 locations and your team is based in the office in the Utrecht area.

The benefits
The company you will be working for offers a competitive salary and good secondary benefits such as 30 holidays, holiday pay, an attractive pension scheme, travel expenses, budget for education and training and an employee committee that organizes fun team activities.
Please note that you will start with a 6 month contract (no probation period) with possibility to extend for another 6 months and even the possibility to enter a permanent contract after the first year.
The Regulatory team comes to the office in the Utrecht area once per week, the other days you can work remotely if you like. Of course you are also welcome to come to the office more often.

What you need to do now
Are you interested in this vacancy as a Regulatory Affairs Specialist? Click on 'Apply' and send an up-to-date CV or call Merel Hasselo on +31620076590. If this vacancy is not exactly what you are looking for, but you are looking for a different position, please contact us for a confidential discussion about your career options. #1044977 #1044977
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Job type
Life Sciences
40-50K gross annualy excluding other benefits

Talk to a consultant

Talk to Merel Hasselo, the specialist consultant managing this position, located in Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Telephone: 0031620076590