For one of our clients located in the region of Zaventem/Diegem, we are looking for an experienced RA Manager.
Do You have a Master Degree in pharmaceutical science, biotechnology or chemistry (or equivalent)?
Do You have minimum 5 years of experience in Regulatory Affairs within the pharmaceutical industry environment?
Are You are trilingual Dutch – French – English (oral and written)?
Then you might be the candidate we are looking for. Don’t hesitate and apply now!
Job Description :
As RA Manager, you are responsible for the planning & follow-up of all regulatory activities for dedicated products. You are responsible for the compiling, submission and follow-up of registration files. You assure products are in accordance with pharmaceutical law.
- You are responsible for the preparation and submission of a marketing authorization dossier, or for a change of such a dossier at the Belgian and Luxemburg authorities and you do the follow-up of this submission by having regular contacts with the authorities and manufacturers/dossier supplier.
- You coordinate extra studies required for the registration files (e.g. stability, validation of methods, BE studies) by having contact with the applicable operation sites.
- You maintain registrations by means of preparing, reviewing and submitting of renewals, Periodic Safety Update Reports, variations (analytical & clinical) and other updates for certain dedicated products.
- You are responsible for the management of the approved documents and for taking care of a correct and timely communication with regards to new or changed data of dossiers of products to other internal departments or or towards internal/external manufacturers.
- You coordinate changes related to packaging materials of products and approval of these towards the packagers/manufacturers.
- You answer to questions from doctors, pharmacists, patients, … with regard to the quality or action of the company’s products.
- You monitor and implement the changes in the Regulatory environment: registration file compliance, renewals of authorizations, …
- You are responsible for every regulatory activity (notification, maintenance, …) related to non-medicinal products (food supplements, cosmetics and biocidal products).
- You are responsible to follow-up all legislation related to medicinal products and non-medicinal products (food supplements, cosmetics and biocidal products).
- You communicate with other departments on all relevant regulatory issues.
- You delegate administrative tasks to RA Assistant(s), you supervise them and if applicable, you give them training.
- You advise Market Access, Medical and Marketing Department in relation to legal aspects, regulatory strategy and positioning of new products.
- You are responsible for the planning, co-ordination and supervision of all regulatory activities needed in order to update national marketing authorizations for all products registered by and/or marketed in Belgium and Luxemburg.
- You prepare the launch of the new registered products.
- You do the planning of post-approval activities of all non-medicinal products.
- You check if current registration file is compliant with the production practice (e.g. by means of PQR-reports, ...).
- You create and/or review Change Control Request and submit subsequent variations. You define strategy for submission of analytical and safety variations (priority setting, planning, …)
- You do the follow-up of all legislation related to medicinal products and non-medicinal products.
- You have a Master Degree in pharmaceutical science, biotechnology or chemistry (or equivalent)
- You have minimum 5 years of experience in Regulatory Affairs within the pharmaceutical industry environment.
- You are trilingual Dutch – French – English (oral and written)
- You have good communication skills
- You are autonomous and take responsibilities.
- You have a positive attitude, you are open and you have a dynamic mindset
- You are flexible
- You are detailed oriented and you are able to handle multiple projects at the same time
- You have strong project management skills
Contact Information :
010 68 53 30