Back to search results Previous

8 of 11


Regulatory Affairs Associate (Senior)

Via Experis Belgium

Published on 4 days ago

Regulatory Affairs Associate (Senior)

Job description

Responsible for providing regulatory support for on- projects. Activities may include submission planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.

  • Act as regulatory liaison to project sub-teams.
  • Responsible for working with other parts of the regulatory organization to achieve desired results
  • Execute global strategic plans and regulatory submissions for sustaining projects
  • Utilize regulatory knowledge to prepare submissions that will achieve desired results
  • Ensure identified standards and content requirements are met for regulatory submissions
  • Timely, actively support query responses and on-site inspections with HAs
  • Engage with business representatives on sub-teams to ensure regulatory activities are in alignment with business requirements
  • Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s)
  • Assist with maintenance activities for regulatory systems and procedures
  • Maintain regulatory files in a format consistent with requirements
  • Track of status and progress of regulatory documentation
  • Review, edit and proofread regulatory documentation
  • Maintain awareness of changing regulatory requirements
  • Execute and document regulatory risk strategies


Scientific knowledge and ability to discuss technical matters with cross-functional team members

  • Knowledge of regulations and ability to communicate and apply will be an asset
  • Good written and verbal communication, presentation, and facilitation skills
  • Experience operating in a regulated environment
  • Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
  • Exercise independent judgement
  • Ability to identify compliance risks and escalate when necessary
  • Comfortable using electronic systems and tools, including Microsoft Office Suite


  • Experience in a healthcare environment
  • Experience in Regulatory affairs (specially from FDA)


Working in international environment with exciting challenge.

Good salary package

Walloon Brabant,Luxembourg,Namur,Hainaut,Eastern Flanders,Limburg,Western Flanders,Flemish Brabant,Antwerp,Liège,Brussels

People also viewed

The job was saved

You can find your saved jobs on the homepage or in My Jobat.

To view them on other devices as well, just log in.

Apply now Apply now

24 days left to apply



  • Master (University or Higher Education Long Type)


  • Permanent
  • Full-time

Apply before

Receive new jobs by e-mail

Receive new 'Quality' jobs in Walloon Brabant, Luxembourg, Namur, Hainaut, Eastern Flanders, Limburg, Western Flanders, Flemish Brabant, Antwerp, Liège, Brussels straight to your mailbox.

We will not send you any advertising.