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Director of Regulatory Affairs

  • Remote, Hybrid
    • Leiden, Zuid-Holland, Netherlands
  • Preclinical Development and CMC

Job description

Leyden Labs is currently looking to hire a seasoned


Director of Regulatory Affairs


In this role you are responsible for the development and successful execution of regulatory strategies, plans and processes for our infectious disease programs. You will be part of a variety of projects, where you’ll be the expert regarding RA. With your expertise and knowledge, you will actively advise the project teams to ensure that Leyden Labs’ programs meet all applicable regulatory and business requirements. In this role, you will be reporting to our CMO.

To be considered for this role, you must have experience as a Regulatory Affairs specialist in Europe and the US. You can take the lead, are used to presenting to and discuss with local and international authorities. Internally, you promote open dialogue to investigate the various options and then work towards a position balancing the various risks and opportunities, externally you have a compelling presence in representing the company and its programs. You feel comfortable making decisions and have a hands-on attitude.


This is what you will do on a daily basis and these are your responsibilities:

  • Lead the development and implementation of a regulatory strategy for our different product programs
  • Apply in depth understanding of regulatory requirements and trends to our programs
  • Ensure the successful adoption and execution of appropriate regulatory strategies and processes and be aligned with short and long-term business strategies and goals
  • Collaborate with management to provide oversight on regulatory matters; and where needed, direct the contributions to meetings with regulatory authorities, key opinion leaders and similar experts and bodies
  • Guide Leyden Lab team members on challenging, complex regulatory and decision-making issues. Share relevant information and drive development of viable strategies and/or methodologies which reflect the most up-to-date regulatory and compliance standards
  • Identify and escalate where appropriate to resolve significant issues and risks

Job requirements

  • MSc in a biomedical field or similar, a PhD would be a plus
  • Proven experience (10+ years) in Regulatory Affairs with experience in Europe and the US, experience in APAC regulatory affairs is a plus
  • Experience in biotech and/or at start-ups is a plus
  • Excellent command of business English


More about you:

  • You are pro-active, hands-on and have a clear communication style
  • Analytically inclined; you make decisions based on facts and figures
  • You are emphatic, you build relationships through honesty, integrity and authenticity and you quickly connect with people


The position is available immediately, but we are willing to wait for the best candidate, we understand you have a notice period or already planned your annual leave. Depending on the geographic location of the candidate remote or hybrid working are possible for this position. At this time we are only considering candidates currently residing on the US East coast or in Europe.

We are an equal opportunity employer; we firmly believe in the added value of a diverse and inclusive group of people with one common goal. We are looking for people who can make an impact and work on a purpose together.

If the purpose of this role and our company ticked all the boxes for your next adventure, please hit the application button and let me know you’re interested by sending me a short cover letter and your cv and I will get in touch within 5 working days (taking into account different time zones) to plan a first call.


Note to all agency recruiters given the important work our employees do, I kindly request that you do not disturb them by approaching our people directly. I'd love to hear from you at jobs@leydenlabs.com

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