Regulatory Affairs Director – Proclinical – Leiden

  • Leiden

Proclinical

Proclinical are recruiting for a Regulatory Affairs Director to join a biotech organisation. This role is on a contract basis and is located in Leiden.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.

Responsibilities:

  • Supervise the regulatory landscape to keep ahead of new developments and efficiently discuss them across the business.
  • Monitor all aspects of regulatory affairs in both a small and dynamic publicly listed business.
  • Guide the preparation of high-quality regulatory applications such as INDs/CTAs and handle the clinical trial approval procedures.
  • Offer training on regulatory expectations to project team members.
  • You will guarantee that the content, quality and format of regulatory proposals comply with suitable guidelines and regulations.
  • Partake in the execution of systems & procedures to develop international business value.
  • Discuss both with internal and external partners, which involves EMA, FDA and any other regulatory authorities.
  • Other duties may be assigned.
  • Key Skills and Requirements:

  • Educated to an advanced degree level in a life science or applied science field.
  • Demonstrable experience in regulatory affairs within a pharmaceutical/biotechnology organisation with expertise on various phases of drug development.
  • Familiarity working with large pharmaceutical organisations with a mix of exposure to smaller organisations with comprehension of the challenges facing a novel company going through rapid enhancement.
  • Familiarity with chairing meetings with regulatory authorities and successful CTA/IND proposals.
  • Acquaintance with liver/cardiovascular diseases, rare disease drug development, evolving technologies and/or platforms and the new EU Clinical Trials Regulation would be beneficial.
  • Communication skills both verbally and in writing.
  • Able to think tactically and creatively with the capacity to make decisions as well as resolve issues.
  • A flexible individual with integrity and a clear sense of responsibility.
  • A result focused individual with a high level of tenacity, enthusiasm and energy.
  • Capable of working cross-functionally/matrix leadership.
  • Works well in a team as well as independently.
  • A patient focused mindset.
  • Able to work within a fast-paced environment.
  • Capable of prioritising various tasks simultaneously.
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