(Associate) Director Regulatory Affairs

☞ Argenx

看过: 120

更新日: 16-11-2025

位置: Ghent East Flanders

类别: 执行管理

行业:

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工作内容

For the expansion of our Regulatory Affairs team, argenx is looking for an (Associate) Director Regulatory Affairs to support the teams in preparation of Regulatory submissions including CTAs/briefing documents for US and EU, IMPD, IND.

Key Accountabilities/Responsibilities:


The position will have the following key responsibilities:

  • Prepares and/or reviews documents for completeness and accuracy; interacts with project team members to assure completeness and timing with regulatory process.
  • Prepares inventory documents based on checklists prepared by regulatory personnel and /or CRO.
  • Prepares and/or reviews regulatory documents for Agencies in US, EU or ROW with R&D team members.
  • Conducts initial review of regulatory agency publications.
  • Prepares and distributes regulatory agency contact reports and meeting minutes.
  • Arranges meetings for regulatory part within project teams or regulatory agency.
  • Increases knowledge of regulations and guidelines and shares new information with regulatory team.
  • With oversight, conducts QC checks of materials prepared by the project team or external.
  • Assists with project management, and other tasks as required by regulatory team members.
  • Attends regular project team meetings.
  • Develops regulatory strategy and prepares and conducts Agency meetings Takes care of the development of risk assessment and risk mitigation
  • Filing of all matters related to nonclinical reports and clinical trials for regulatory activities from Phase 1 to 3 according to CTD.
  • Supports in preparation of activities prior to BLA/MAA.
  • Provides responses to regulatory agencies with support of the project team. Ensure that the document content is aligned with regulatory expectations in US, Japan and EU.

Desired Skills and Experience:

  • > 5 years of relevant experience in (clinical) Research and Development within the pharmaceutical or biopharmaceutical industry.
  • Applying domain knowledge: Merely possessing knowledge is not the key. Knowing how to apply domain knowledge in the field of regulatory framework development is very important.
  • Excellent interpersonal skills – able to work well and build relationships across a diverse set of stakeholders and characters.
  • Sound judgement and ability to analyze situations and information. Takes decisions based on facts and figures rather than on assumptions.
  • Excellent project management skills.
  • Flexible mindset and resistant to stress and changes in strategy.
  • Able to travel based on business needs.
  • Medical writing skills is an asset.
  • Fluent in English (oral and written).
  • University degree, Master in Life Sciences.

Offer:

  • A competitive salary package with benefits;
  • A work environment in a human-sized, dynamic, rapidly growing biotech company
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最后期限: 31-12-2025

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