Regulatory Affairs Officer

  • Permanent
  • Pharmaceutical

You ensure the planning and realization of the Regulatory Affairs activities in line with the established procedures (RA/RIP SOPs). Develop good contacts with customers where professionalism, image and impeccable quality are guaranteed.

Vacancy information

CORE ACTIVITIES

  • Jointly responsible for realizing the necessary registrations for medicines and notifications for health products and cosmetics so that products can be placed on the market. This includes tasks such as the delivery of technical and medical documentation, ensuring the translation of package inserts and labelling, submitting dossiers via e-submission, following up and responding to deficiency letters.
  • Monitoring the life cycle of medicines, medical devices, food supplements, biocides and cosmetics through follow-up so that products can remain on the market in accordance with legislation by submitting variations and notifications. Layout, customization and verification of SPC, PIL and label.
  • Provide medicines with a price, a price increase and possibly a reimbursement fee so that they can be marketed at an acceptable price level after positive advice from CTG.
  • By performing a readability test (RUT) to check whether package leaflets of medicines are clear to consumers so that they can be registered, based on questionnaires & interviews. Create RUT reports.
  • Privileged contact person with FAMHP and competent authorities regarding Regulatory Affairs.
  • Investigate the wishes and needs of the customer and act accordingly. Anticipating customer needs. Giving high priority to service willingness and customer satisfaction. Prepare meetings with clients, provide them the minutes, and follow up.

Requirements information

REQUIRED COMPETENCES

  • Customer orientation: Investigating the wishes and needs of the customer and acting accordingly. Anticipating customer needs. Giving high priority to service willingness and customer satisfaction.
  • Collaboration/Collegiality: Making an active contribution to a joint result or problem solution. Collaborating means thinking and cooperating with the other(s), making an effort to achieve the joint result.
  • Organizational: Determining goals and priorities in an effective way and indicating the time, actions and resources required to achieve certain goals.
  • Self-development: Having insight into your own strengths and weaknesses. Based on this, take actions to increase/improve own knowledge, skills and competencies and thus perform better.
  • Quality-oriented/accuracy: carrying out, checking work carefully and completely, using checklists where possible to ensure that no errors or omissions remain undetected.

EDUCATION / EXPERIENCE

  • Master of Life Sciences, preferably M.Sc. Pharmacy
  • Strong communication skills (DU/ENG/FR)
  • Affinity with European legislation and regulations for medicines and health products.
  • Preferably, a first relevant work experience in Regulatory Affairs.

Myriam Van Londersele

Vacancy ID: 565

Business Development Manager & Sr. Recruiter

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