RA & Labelling Associate

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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