Center of Excellence Regulatory Lead

il y a 1 semaine


Gent, Flandre, Belgique Argenx Temps plein
For the expansion of our Regulatory team, argenx is looking for a Center of Excellence Regulatory Lead who is responsible for:
  • managing the team of regulatory associates that performs regulatory oversight for the individual studies.

Key Accountabilities/Responsibilities:

  • Maintain an indepth knowledge of the fastevolving global clinical trial regulations
  • Develop and maintain a regulatory intelligence database to centralize handson knowledge on (local) regulations and internal experiences regarding clinical trial submissions
  • Actively liaise with other functions involved in clinical trial submissions in order to optimize clinical trial startup timelines
  • Advise clinical trial teams during study planning, setup and conduct
  • Oversee the team of regulatory liaisons and ensure the appropriate regulatory oversight for all clinical studies
  • Provide training to educate functional areas on regulatory changes and lessons learned
  • Adapt and optimize processes related to clinical trial submissions to comply with new regulation(s) and gain efficiency
  • Identify the need for new processes and develop these together with the relevant functional areas
  • Develop, update and maintain procedural documents as needed

Desired Skills and Experience:

  • Excellent communicator
  • Builder of interdepartmental relations
  • Working knowledge of current global clinical trial regulations
  • Handson approach to support CTT team(s)
  • Independent, quick learner
  • Prioritize effectively in a fastpaced environment
  • Excellent organizational skills and attention to detail
  • Leadership skills and critical thinker to find solutions with the teams for various problems and make decisions
  • Analytical mind to understand, analyse and optimize processes and procedures
  • Highly selfmotivated
  • Computer literacy, proficiency in MS Word, Excel, PowerPoint, Acrobat Pro, etc
  • Master degree or PhD in scientific or biomedical field
  • 10+ years of experience in clinical development role (preference given to regulatory affairs)
  • Deep understanding of clinical trial submission process:
  • Experience in the submission and maintenance of clinical trials worldwide
  • Expert in the EU Regulation 536/201
  • Experience with the US IND submission process
  • Familiarity with clinical trial documents and clinical development design
  • Experience in improving processes and update/create related Procedural Documents
  • Experience with writing review summaries and developing training material
  • Knowledge of project management

Offer:

  • A competitive salary package with extensive benefits;
  • A work environment in a successful, dynamic, rapidly growing biotech company.

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