Regulatory Affairs Manager

For one of our clients, a biotech company located in East-Flanders, we are looking for an experienced Regulatory Affairs Manager.

  • Do you have more than 5 years of relevant experience in Clinical Research and Regulatory Affairs?
  • Are you fluent in English?
  • Do you have a flexible mindset and excellent interpersonal skills?  

Then apply as soon as you can!

Job Description 

The Regulatory Affairs Manager supports the Regulatory Affairs team in preparation of Regulatory submissions including CTAs/briefing documents for US and EU, IMPD, IND.

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.
Profile 
  • > 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. 
Contact Information 

Nele Daems

nele.daems@valesta.com

015 21 11 04

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