As a Regulatory Affairs Officer you are responsible for obtaining registration of new medicines and you maintain existing registrations of medicines. You are responsible for translating, preparing and updating the labeling and packaging of medicines, such as the SPC-text (Summary of Product Characteristics), the shortened SPC-text, the package leaflet texts and the packaging texts (labeling) for various packaging formats.In cooperation with the Drug Safety- or Pharmacovigilance Department, Medical Affairs and various HeadQuarter Departments, you review the Periodic Safety Update Reports (PSURs) and submit them in time to the Medicines Evaluation Board (MEB), the EMA (European Medicine Agency) or the FDA (Food and Drug Administration).
In addition, you play a crucial role in the approval of promotional materials, the documentation and other requirements for conducting clinical drug studies , as well as an important role in the support for market access (admission and reimbursement of medicines to the market) and all further legal requirements for the logistical delivery of medicines to pharmacists and wholesalers. Depending on the organization you report to a Regulatory Affairs Manager or Head Regulatory Affairs. Synonyms for the Regulatory Affairs Officer are Regulatory Affairs Associate and Regulatory Affairs Specialist.
Some tasks/responsibilities of a Regulatory Affairs Officer:
- Submitting (adjustments to) registration dossiers to the Medicine Evaluation Board and supervising the registration procedure in order to obtain and maintain registration through interaction with (inter) national heath authorities and the Headquarter relevant departments in case of concerns;
- Assessing and, if necessary, advising on adapting the chemical-pharmaceutical part of registration dossiers and, in collaboration with Medical Affairs, preparing corresponding letters with arguments to the Medicines Evaluation Board (MEB), international Health Authorities and the Head Office;
- Ensuring compliance with the Risk Management Plan (RMP), the accompanying educational materials and ensuring timely MEB assessment of related educational materials;
- Contributing to various product strategic plans regarding timing, opportunities and threats with regard to regulatory matters of both own and competitive products, including Regulatory Advocacy;
- Checking packaging material, package leaflets in accordance with the quality requirements set by pharmaceutical company and the legislator;
- Assessing the medical scientific correctness and conformity with the SPC of promotional material, with regard to the Medicines Act and the Code of Conduct for Pharmaceutical Advertising;
- Maintaining contacts and sharing relevant information with relevant disciplines, internally and externally, nationally and internationally (marketing, medical, clinical, headquarters, R&D, health authorities and external experts).
Your background and profile:
- Completed scientific education (Master) in a (bio) medical or biopharmaceutical direction;
- Excellent computer skills;
- Excellent writing skills in the Dutch language;
- Knowledge of medical termininology;
- Knowledge of pharmacology;
- Good communication skills in Dutch and English.
Terms of employment and salary
Terms of employment and salary are variable and depending on experience. Je startsalaris ligt ongeveer in een range van € 35.000,- € 42.000 euro per jaar. Usually you will also have a bonus scheme.
Interested in a position as a Regulatory Affairs Officer?
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