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RA & Labelling Associate

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Laura Schollen
Career Manager



Laura Schollen
Career Manager
+32 494 04 21 32


Job description

To provide regulatory advice and support to the organization on the content of existing marketing authorizations and for products in development phase.

Main Accountabilities

  • Follow-up with the Area team to obtain marketing authorizations for new pharmaceutical products, and work proactively with the affiliate commercial teams on local launch activities
  • Maintain marketing authorizations as required
  • Acts as Variations Officer and Carton & Label Operator
  • Liaise with Western European Regulatory Affairs and Corporate groups on regulatory matters
  • Liaise with national regulatory authorities as required
  • Comply with the Company’s policies and procedures to assure consistency of the current local prescribing information with the CCDS in order to:

- Ensure alignment within the organization

- Meet the expectations of regulatory agencies

- Implement approved label through defined artwork process

  • Liaise and attend meetings with other company functions to provide regulatory advice for new and existing products, including participation within affiliate Brand Team
  • May be involved in arrangement of national Scientific Advice with national Competent Authorities
  • Maintain awareness of current and new legislation/guidance (EU, BE, LUX) and ensure that work is in compliance with the statutory requirements
  • Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable
  • Functions as a subject matter expert both within regulatory advertising and promotion and related functional areas
  • Verification of promotional materials for compliance with current approved labeling and pricing information.
  • If required, coordinating the review of parallel import samples

Profile

  • Scientific/Biomedical degree/(Industrial) Pharmacist
  • Several years of Regulatory experience or in a related area in Healthcare industry
  • Good communication skills, both verbal and written
  • The ability to thrive in a changing environment and to re-prioritize workload to meet business needs
  • Good project management skills essential
  • Good Dutch, French and English language skills
  • Customer oriented
  • Strong analytical skills, accurate end efficient

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Contact details

Education and experience

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+32 494 04 21 32