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Associate Director Regulatory Affairs

4 weken geleden

Rotterdam, Nederland Walker Cole International Voltijd

Walker Cole International is working with a leading life science consultancy company specialising in supporting biotech's through the complexities of the regulatory landscape.


This is a full-time position which can be based in the Netherlands (hybrid/remote working possible). Our client is seeking a knowledgeable Associate Director Regulatory Affairs on a permanent basis and you will play a pivotal role in guiding their clients through the regulatory process, helping them navigate challenges from early-stage development through to commercialisation. Your expertise will be critical in ensuring the successful submission and approval of regulatory filings, as well as in providing strategic regulatory advice.


Key Responsibilities as the Associate Director Regulatory Affairs:

  • Provide regulatory consulting services to biotech/pharma clients, ensuring compliance with regulatory requirements in key markets (FDA, EMA, etc.).
  • Develop and execute regulatory strategies for clinical trial applications, IND submissions, orphan drug designations, and market authorizations.
  • Prepare and review regulatory documents, including submission dossiers, briefing packages, and responses to regulatory queries.
  • Advise clients on regulatory best practices, submission timelines, and risk mitigation strategies.


To be successful in your application for the Associate Director Regulatory Affairs position, you will have the following expertise:

  • A minimum of 3-5 years of experience in regulatory affairs, with a focus on biotech, pharmaceuticals, or related industries.
  • Knowledge of FDA, EMA, and other global regulatory agencies and submission processes.
  • Experience in the preparation and submission of regulatory documents (e.g., IND, CTA, NDA, MAA).
  • Strong understanding of regulatory guidelines, drug development processes, and market approval pathways.
  • Exceptional communication and interpersonal skills, with the ability to build strong relationships with clients and regulatory bodies.



Regulatory Affairs | Associate Director Regulatory Affairs | CTA | MAA | Scientific Advice | EMA | IND | Biotech | Pharma | FDA | EMA