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Regulatory Affairs Specialist

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Our client is a global innovator in the biotechnology and pharmaceutical sector, committed to developing breakthrough therapies that improve and extend lives. They are expanding their regulatory team and currently seeking a Regulatory Affairs Specialist to support the development and approval of life-changing products across global markets. If you're passionate about bringing safe and effective therapies to patients and thrive in a fast-paced, regulated environment, this is the opportunity for you.

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randstad - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

As a Regulatory Affairs Specialist, you will play a key role in compiling, reviewing, and submitting regulatory documentation to health authorities such as the EMA and FDA. You’ll work cross-functionally with R&D, Quality, and Clinical teams to ensure compliance throughout the product lifecycle—from early development to post-marketing support. Your responsibilities will include preparing regulatory submissions (CTAs, INDs, MAAs, NDAs), responding to authority queries, maintaining product registrations, and monitoring regulatory changes that may impact the organization. You will also contribute to regulatory strategy development and support audits and inspections by ensuring that documentation is current, accurate, and audit-ready.

QTC logo icon what's needed

What you bring

You, as the ideal Regulatory Affairs Specialist, will recognize yourself in the following:

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field
  • 3+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industry
  • Working knowledge of EU and US regulatory requirements (e.g., EMA, FDA, ICH guidelines)
  • Experience with regulatory submissions such as INDs, CTAs, NDAs, MAAs
  • Strong attention to detail and excellent communication skills in English (both written and verbal)

QTC logo icon What we offer

What's in it for you

What we offer:

We offer you the opportunity to join a company where your contributions will play a key role in shaping its future. You’ll work in a dynamic and stimulating environment, alongside a collaborative and supportive team. As the company continues to grow, you’ll benefit from ample opportunities for professional development. In return, you’ll receive a competitive compensation package, including a pension plan.
 

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