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Regulatory Affairs Associate (Senior)

Via Experis Belgium

Published on Jobat.be 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

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:

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

Offer

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

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24 days left to apply

Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Full-time

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