Regulatory Affairs Officer (Senior/Medior)
Full-time | Or open for 32-36 hours
Join a global pharmaceutical leader and help shape the future of accessible healthcare.
Due to growth, we are looking for two experienced Regulatory Affairs Officers to strengthen our team. With your expertise, you can make a real impact in bringing high-quality, affordable medicines to patients across Europe.
Your role
As a Regulatory Affairs Officer, you will be the driving force behind the registration and lifecycle management of our medicinal products. You will:
Manage timely registration and maintenance of marketing authorisations at both national and EU level.
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Lead submission processes for new and existing products with health authorities.
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Ensure accurate documentation in our regulatory systems and databases.
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Communicate effectively with internal teams and external stakeholders on dossier updates, compliance, and approvals.
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Review and approve Regulatory Compliance Files.
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Collaborate closely with Quality, Artwork, and Supply Chain teams.
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Keep up to date with regulatory legislation and market developments.
What we offer
An open, informal, and collaborative work environment.
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Short communication lines and plenty of room for your input.
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A temporary contract with the possibility of a permanent position.
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Competitive salary, bonus scheme, and extra vacation days.
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Excellent pension plan.
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Flexible working hours (32-36 hours) and partial remote work by agreement.
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Well-being perks such as monthly chair massages, social activities, and access to our online learning academy.
Your profile
Relevant higher professional degree.
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At least 5 years of experience in regulatory affairs within the pharmaceutical industry.
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Hands-on, stress x2011;resistant, precise, and quality x2011;focused.
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Strong organisational skills and solid knowledge of regulatory requirements.
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Excellent communication skills in Dutch and English.
Our values
Delivering quality
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Taking responsibility
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Embracing collaboration
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Driving growth
If this sounds like your next step (permanent or interim), send your CV and motivation to our HR team.
To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesin.eu) you saw this job posting.
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