Regulatory Affairs Officer - Pharmaceutical

Regulatory Affairs Officer

I am partnered with an international Pharmaceutical company who are highly motivated in expanding their Regulatory Affairs personnel in Belgium. This company are a very niche, specialist organisation and have an excellent pipeline of interesting and complex products. 

We have teamed up and together, we are looking for an experienced Regulatory Affairs Officer to be a part of this passionate team.

Responsibilities:

• Helps with due diligence and incorporation of new products.
• Regulates the tactical and operational direction for the continuous improvement of the BU RA management systems. 
• Devising and submitting license requests and variations towards the local authorities. 
• Complete the report by creating product specific forms such as application form, declaration of conformity & of integrity.
• Assemble the draft PIA (parallel import authorization) and seek for information related to the imported medicinal product such as composition, indication, visual parameters as described within the specification.
• Comparison of the leaflet of the Belgian reference medicinal product with product that has been imported.
• Maintaining start / stop commercialisation, communicating product availability or shortages with the Belgium Federal Agency.  
• Approval of product artwork and contributing to any changes.
• Monitoring of the Regulatory database.
• Supporting the upkeep of the Quality Management System.
• Staying on top of any new regulatory alterations.
• Offer expert support to line management in incident investigation and reporting & advice regarding all RA health and safety matters on site.

Experience required  

• Sound knowledge of the relevant European regulations for manufacturing of pharmaceutical products.
• At least 4 years of experience in pharmaceutical Regulatory Affairs.
• Strong project management skills ability to communicate fluently in Flemish. 
• Master (in pharmaceutical sciences, engineering, biochemistry, chemistry) or equivalent.  
• Highly motivated and passionate individual.
• Able to adapt to any change in priorities. 
• Always looking of ways to improve or develop.

This is a fantastic opportunity within a brilliant company and if you feels as though you posses the necessary work history and skills for this role then please do get in touch by making an application with your CV attached.

Reece Coaker

Reece.coaker@rbwconsulting.com

+44 (0)1293 584 300

Key words

Regulatory Affairs / RA / RA Officer / Regulatory Affairs Officer / Regulatory Affairs Associate / Pharma / Pharmaceutical / Parallel Imports / Generics / Belgium