Regulatory Affairs Officer

In accordance with the provisions of the respective laws and applicable internal procedures provide regulatory advice and support to the organization regarding the content of existing marketing authorizations and products in development phase, including medical devices, for both the AbbVie therapeutic portfolio in Belgium and Luxembourg, and the Allergan Aesthetic portfolio in Belgium, Luxembourg and The Netherlands.

Main responsibilities

Review of promotional and non-promotional materials

• Contribute to the creation of promotional campaigns for the medicines and medical devices in your portfolio, particularly in collaboration with the marketing department, the medical department and the Responsible Information & Publicity (RIP).
• Review and approve promotional and non-promotional materials in accordance with legislation, local procedures and codes of practice

Marketing authorizations

• Monitor the obtention of the marketing authorization registration of your products, in close coordination with EU regulatory affairs
• Manage the marketing authorization dossiers in accordance with Global instructions and the current registration procedure.
• Ensure compliance with the marketing authorization by creating, updating, and making available product information and packaging materials, in alignment with the Company’s policies and procedures. This includes assuring consistency of local product information with the CCDS to ensure organizational alignment, meet regulatory agency expectations, and implement approved labeling through the 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(s) and collaboration with the affiliate commercial teams on local launch activities.
• Liaise with EU regulatory affairs on regulatory matters related to the products in your portfolio to respond to affiliate’s business need
• Collaborate with Medical functions to develop early access programs for the products in your portfolio
• Acts as Variations Officer and Carton & Label Operator (see separate function descriptions)

Medical devices and devices under Annex XVI of Medical Device Regulation

• In collaboration with QA department, manage regulatory activities related to medical devices and devices under Annex XVI of Medical Device Regulation. This includes assuring consistency of instructions for use in local languages with the English, and implementing approved labeling through the defined artwork process

Procedures and legislation

• Review global procedures to determine impact on local procedures
• Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable
• Maintain awareness of current and new legislation (EU, BE, LUX, NL for Allergan Aesthetics) and ensure that work is in compliance with the statutory requirements

Required Education / Knowledge / Experience

• Scientific degree/Biomedical degree/Pharmacist
• Several years of Regulatory experience or in a related area in pharma industry
• Strong meticulousness, good analytical thinking
• Good communication skills, both verbal and written
• Organizational skills, managing deadlines, multiple projects, and documentation efficiently
• Ability to adapt and thrive in a dynamic environment by managing shifting priorities, responding effectively to changes in regulations and company policies, and overseeing multiple portfolios to meet evolving business needs.
• Good collaboration/teamwork mindset
• Customer-focused and results-driven
• Good Dutch, French and English language skills

AbbVie Culture

At AbbVie, we care deeply about bringing innovative solutions to patients in need. By joining us as a Product Specialist, you'll be at the forefront of our mission, working in a dynamic and supportive environment that encourages growth and collaboration.

• All4OneAbbVie: Foster strong interpersonal relationships and teamwork.
• Decide Smart & Sure: Navigate ambiguity and make informed decisions.
• Agile & Accountable: Communicate a clear and inspiring vision.
• Clear & Courageous: Provide honest and constructive feedback.
• Make Possibilities Real: Efficiently plan and execute tasks while adapting to challenges.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer...