Expires soon BAXTER SAS

INTERNATIONAL REGULATORY AFFAIRS ASSOCIATE HF

  • V.I.E.
  • Braine-l'Alleud (Brabant Wallon)
  • Marketing

Job description

Entreprise:
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Poste et missions:
- 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 in English
- 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
- Master 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

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