Regulatory Affairs Manager

Accountabilities/Responsibilities:
*The function of the Regulatory Affairs Manager consists in the support of the Director in handling registration files of products registered in the Benelux via national, MRP and centralised procedures.
*Elaborate, compile and update the registration files: adapt to national requirements, submit to the Benelux Health Authorities, updating of leaflets, packaging materials.
*Monitor and implement the changes in the Regulatory environment: registration file compliance, renewals of authorisations
*Communicate with the other departments on all relevant regulatory issues.
*International contacts.
*Contacts with several official agencies.
*Follow-up and interpretation of national and European legislation.
*Pharmacist. Being an industrial pharmacist is a plus.
Essential Skills & Capabilities:
*Minimum 5 years experience in a similar function within a pharmaceutical industry.
*Trilingual FR/EN/Dutch.
*Inclination to computer tools and Quality Systems.
*Initiative, autonomy.
*Flexibility and team spirit.
*Communication skill.

*They offer :
*a human work environment within a dynamic company
*an attractive salary and excellent company benefits
*functions with large responsibilities and great autonomy
*an enthusiastic team with strong implication in work.