freelance
Regulatory Affairs Associate Reference number: 1200
Last update: 18-11-2019, 15:59
Region: Braine L'Alleud
Sector: Pharmaceutical
Education: Bachelor’s degree or country equivalent in pharmacy or related scientific discipline. Higher degree/PhD will be an advantage.
Start: 02 Dec 2019    End: 30 Mar 2020
Work experience: A minimum of 5 years
Job description
Responsible for the implementation of complex regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of our client’s products. Serves as a consultant to managers
What you’ll do
  • Compile and submit in a timely manner, regulatory documents according to regulatory requirements.
  • Prepare review and approve labeling and SOP’s. Assist lower level team members on complex issues.
  • Provide regulatory advice to project teams.
  • Provide guidance and coaching for areas of responsibility to lower level team members.
  • Respond to regulatory authorities questions with strict deadlines.
  • Maintain regulatory files in a format consistent with requirements.
  • Develop and initiate complex regulatory project plans.
  • Manage regulatory activities relating to specific portfolio of products/projects (product owner).
  • Maintain and update existing regulatory authorizations.
  • Lead or represent Regulatory Affairs in project teams.
  • May review promotional material for compliance with local regulations.
  • Use of critical systems such as BPLM, BaxEdge, Trackwise,...
Profile
  • Bachelor’s degree or country equivalent in pharmacy or related scientific discipline.
  • Higher degree/PhD will be an advantage.
  • Number of years of experience: A minimum of 5 years
  • Field of expertise: Regulatory or equivalent experience within a pharmaceutical company CRO, or similar organization.
  • Experience in dealing with Belgian authorities is required
  • Experience in dealing with Netherlands authorities is a plus
Required Skills
  • Comply with regulations and standards and protect the client's public reputation.
  • Exercise independent judgment.
  • Scientific knowledge.
  • Written and verbal communication skills.
  • Knowledge of regulations.
  • Strong negotiation skills.
  • Technical systems skills (e.g. word processing, spreadsheets, databases, online research).
  • Manage multiple projects and deadlines.
  • Ability to identify compliance risks and escalate when necessary.
  • English Fluent. French / Dutch: fluency in one and good knowledge of the other
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