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Regulatory Affairs Liason

  • Type Contract
  • Salary Negotiable
  • Location Walloon Brabant, Belgium
  • Sectors Pharma & Biotech

Regulatory Affairs Associate (Senior):

Real Life Sciences is currently looking for a Regulatory Affairs Senior Associate for one of its clients, a pharmaceutical company based in Walloon Brabant.

You will be 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.

The Project

  • 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

The Profile:

  • 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

Required:

  • Bachelor's Degree or country equivalent in related scientific discipline
  • Higher degree/PhD will be an advantage
  • Experience in a healthcare environment required/will be an advantage
  • Experience in Regulatory affairs (specially from FDA) will be an advantage