(Associate) Director Regulatory Affairs

(Associate) Director Regulatory Affairs

argenx

Ghent, Belgium

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.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Belgium     Clinical Research     Manager and Executive     Pre-clinical Research and Development     Regulatory Affairs     argenx    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies