Associate Regulatory Affairs

One of our clients in Breda is looking for an Associate Regulatory Affairs!

Do you have a good written and verbal knowledge in English and Dutch?

Do you want to work 22,5 hours per week / 3 days per week?

Do you have an administrative education or a high school diploma with some experience in GMP/GDP?

Then you are the candidate we are looking for. So please apply today to find out more!

Job Description 

The Associate Regulatory Affairs is responsible for the registration document(s) procurement, preparation and coordination. 
The Associate Regulatory Affairs will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation. 
He/she works in collaboration with the Site RA CMC Team and other Global/Regional Teams as needed. 

Responsibilities 

- Registration document(s) procurement, preparation, coordination submission and archival.
- Coordinates legalization and delivery of registration documents following the instructions provided in the request. 
- Maintains tracking and organization of documentation, including uploading in CSD tool or other document repositories. 
- Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed. 
- Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses. 

Profile 

- High school diploma with basic experience or administrative education without experience. 
- Good knowledge written and verbal (English and Dutch).
- Knowledge of Good Manufacturing Practices (GMP) and good documentation practices is a pre.
- Strong written and oral communication skills.
- Proficient use of MS Office tools, SharePoint and strong computer aptitude. 
- Must have the ability to work within a team environment, but maintain a level of autonomy for managing daily tasks and activities.
- Solid working knowledge on document management systems such as Documentum. 

Contact Information 

Claire Aerts
+32 15 21 11 04
claire.aerts@valesta.com

Application form : Associate Regulatory Affairs

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