REGULATORY AFFAIRS (RA) OFFICER

As an RA Officer, you will carry out all regulatory actions to obtain and maintain permits/registrations to commercialise products, within the predetermined deadlines and in accordance with the applicable regulations.

Taken:

• Preparing, drafting, submitting (possibly in collaboration with external partners) and following up the registration dossiers in accordance with the applicable guidelines.
• Carrying out all necessary actions necessary to maintain the permit/registration (variations, renewals, notifications, PSUR, etc.).
• Formulate proposals to the RA Manager about the possible approach and planning of the registration procedure.
• Coordinate the registration procedure in the countries concerned, after validation of the working method and planning by the RA Manager.
• Analyse the regulatory impact of making changes to existing products. This includes changes to the quality part (production, analysis, specifications, APIs/raw materials,.. etc), as well as the clinical part (indications, side effects, claims,.. etc) of the file.
• Compliance with legislation and detailed regulatory and scientific guidelines in the countries concerned for products with different legal statuses.
• Answer the questions asked for certain products by the relevant authorities, pharmacists, doctors or customers, after internal and/or external consultation and validation by the RA Manager.
• Prepare impact analysis in response to changes in the applicable regulations and formulate proposals for recommendations to ensure compliance.
• Reviewing and approving all packaging material and proofreading (and possibly notifying) advertising and promotional material.

Profile:

• You have a master's degree in a scientific field such as pharmaceutical sciences (pharmacist), drug development, biomedical sciences, bioengineering, (bio)chemistry or similar
• You have several years of RA experience in a pharmaceutical company.
• You are familiar with the different stages in drug development and production in a pharmaceutical company.
• You have a good knowledge of the relevant national, European and international legislation, procedural regulations and technical rules for products with different legal statuses.
• You can work independently and in an organized way.
• You have an excellent sense of priorities.
• You work very accurately.
• You are flexible and you can adapt to changing circumstances/needs.
• You stay up to date with evolutions in the field.
• Your mother tongue is Dutch and you have a fluent knowledge of French and English.
• You have a good knowledge of Word, Excel and Outlook