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Senior Regulatory Affairs Associate

Via Pauwels Consulting

Published on Jobat.be 12 days ago

Pauwels Consulting is a Belgian consulting firm with more than 520 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .

Senior Regulatory Affairs Associate

Job description

• 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 
• Maintain regulatory files in a format consistent with requirements 
• Review, edit and proofread regulatory documentation 
• Maintain awareness of changing regulatory requirements 
• Execute and document regulatory risk strategies 

Profile

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

• Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines 
• Ability to identify compliance risks and escalate when necessary 
• Comfortable using electronic systems and tools, including Microsoft Office Suite 
• Good written and verbal communication, presentation, and facilitation skills 

Offer

  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
Nivelles

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16 days left to apply

Characteristics

Requirements

  • Academic Bachelor

Offer

  • Permanent
  • Independent
  • Full-time

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