Senior Regulatory Affairs Officer
Do you want to be a Regulatory Affairs Officer for the global market leader in pharmaceutical development services? This large pharmaceutical company operates worldwide and is looking for a Regulatory Affairs Officer for their location in Noord-Brabant, the Netherlands. In this position you will support the RA department with two other RA professionals and you will report to the RA Manager on site. It is an exciting position with a variety of tasks and possibilities.
These will be your tasks and responsibilities:
- The registration dossiers (CMC, non-clinical and clinical). You will be preparing and filing these dossiers in conformity with regulations and guidelines;
- You will represent Regulatory Affairs in project teams that are responsible for developing new products. Your task will be to ensure that the development of these products is in compliance with EU regulations and ICH guidelines;
- You will be providing regulatory support to customers and maintenance of MA's of this company;
- The bioequivalence study will be one of your responsibilities. This includes that you will be setting-up the study in accordance with guidelines. In addition you will be responsible for the preparation of IMPD/CTA, monitoring and labelling study samples;
- You will gather regulatory information which could be relevant and interesting to add to the portfolio;
- You will use regulatory information to evaluate possibilities for new products;
- You will also participate in meetings and review and sign regulatory affairs documents.
You will need to have the following skills:
- Bachelor of Science degree or higher related to Pharmacy, Chemistry or Health Science;
- At least five years of experience in a Senior Regulatory Affairs position;
- You have knowledge of European and MRP/DCP submissions;
- Knowledge of GMP is required;
- Knowledge GCP/GLP and CP submissions is preferred;
- Knowledge of FDA regulations is a plus;
- You speak fluent English;
- You have good communication skills;
- You are result-driven.
- +/- €55k-€65k (based on a fulltime gross yearly salary, depending on knowledge and experience)
- 8% holiday allowance
- 10% bonus
- Growth opportunities within the organization;
- Travel allowance (0,19 cent p/km with a max of €200,00 a month)
- The company offers €25,00 a month for sport memberships
Interested in this role?
Are you the Senior Regulatory Affairs Officer I am looking for? Please don't hesitate to contact Joey Wielkens on the phone number 020-5221577 or send an e-mail to j.wielkens @ realstaffing.com. You may also contact me if you have questions about this role.
€ 55.000,00 - € 65.000,00 /jaar