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Regulatory Affairs Associate

Pauwels Consulting | Braine-l'Alleud | Permanent, Independent, Full-time

Published on Jobat.be 15 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/) .

Regulatory Affairs Associate

Job description

  • Develop global regulatory project plans, including a detailed list of submission deliverables, dependencies, approval timing and cost
  • Compile regulatory documentation in support of medical device and drug submissions in accordance with local regulatory requirements
  • Create / maintain overall schedule for global registration activities, and communicate accomplishments and risks to global project team
  • Coordinate responses to regulatory authority queries with strict deadlines
  • Support Country RA to maintain and update existing regulatory authorizations
  • Prepare / update product labelling

Profile

  • Bachelor's degree or country equivalent in engineering, chemistry, or related scientific discipline
  • A minimum of 5 years of regulatory or equivalent experience within a pharmaceutical company or similar organization
  • A medical device global regulatory experience is advantageous
  • Project Management Experience / PMP Certification will be an advantage
  • Excellent written and verbal communication skills
  • Ability to manage complex / multiple projects and deadlines effectively

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

Interested?

Bezoek pauwelsconsulting.com voor meer informatie over de vacature Regulatory Affairs Associate of solliciteer online op de vacature Regulatory Affairs Associate.

Nivelles

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45 days left to apply

Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Independent
  • Full-time
  • Company car

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