About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Overall responsibilities:

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 (see separate function descriptions)
• 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

 

Qualifications

Required Education / Knowledge / Experience:

• 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

Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.