Regulatory Affairs Officer

What does a Regulatory Affairs Officer do?

As a Regulatory Affairs Officer within Regulatory Affairs, you are responsible for obtaining registration of new medicines and you maintain existing registrations of medicines. Your job description may include you being involved in translating, preparing and updating the labelling and packaging of medicines. For example, the summary of product characteristics texts (SmPC), (and shortened SmPC text), the package leaflet texts and labelling for various packaging formats. In cooperation with the Investigational Product Safety or Pharmacovigilance Department, Medical Affairs and various headquarters departments, you review the periodic safety update reports (PSURs) and submit them in time to the Medicines Evaluation Board (MEB), the European Medicine Agency (EMA) and/or the Food and Drug Administration (FDA).

Your job may also involve playing a crucial role in the approval of promotional materials, the documentation and other requirements for conducting clinical 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 organisation, you report to a Regulatory Affairs Manager or Head of Regulatory Affairs. An Regulatory Affairs Officer may also be known as a Regulatory Affairs Associate or a Regulatory Affairs Specialist.

Take a look at the Regulatory Affairs Officer vacancies to see which are the best fit for you!

What responsibilities can you expect as a Regulatory Affairs Officer?

As an RA Officer, your job description may include the following:

• submitting adjustments to registration dossiers to the MEB and supervising the registration procedure to obtain and maintain registration through interaction with national and international health 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 MEB, international Health Authorities and the Head Quarters (HQ);
• 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 relating to regulatory matters of both your company’s own and competitive products, including regulatory advocacy;
• checking that leaflets and packaging material comply with the quality of the pharmaceutical company and the legislator;
• assessing the medical scientific correctness and conformity with the SmPC of promotional material, in relation 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).

Need more details? Browse our Regulatory Affairs Manager vacancies

What education and skills do you need as a Regulatory Affairs Officer?

Regulatory Affairs Officer education and skills requirements will vary according to the role and the employer, but are likely to include the following:

• completed scientific education (master’s) in a biomedical, biopharmaceutical or life sciences area;
• excellent computer skills;
• excellent writing skills in the Dutch language;
• knowledge of medical terminology;
• knowledge of pharmacology;
• good communication skills in Dutch and English.

What salary can you expect as a Regulatory Affairs Officer?

Terms of employment and salary for an RA Officer are variable and depend on experience. The starting salary in the Netherlands is usually in the range of €36.000,- – €72.000,- per annum. There may also be benefits such as a bonus scheme. You may have the opportunity to progress to Senior Regulatory Affairs Officer, with a higher salary and more responsibility.

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