AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company focuses on key therapeutic areas including immunology, oncology, neuroscience, and the Allergan Aesthetics portfolio.
Job Description
Provide regulatory advice and support to the organization regarding the content of existing marketing authorisations and products in development, 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 medicines and medical devices in your portfolio, collaborating with marketing, medical, and the Responsible Information & Publicity (RIP) teams.
* Review and approve promotional and non‑promotional materials in accordance with legislation, local procedures, and codes of practice.
Marketing authorisations
* Monitor the acquisition of marketing authorisation registration for your products in close coordination with EU regulatory affairs.
* Manage marketing authorisation dossiers in accordance with global instructions and the current registration procedure.
* Ensure compliance by creating, updating, and making available product information and packaging materials, aligned with company policies and procedures.
* Liaise with other company functions to provide regulatory advice for new and existing products, including participation within affiliate Brand Teams and collaboration with 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 business needs.
* Collaborate with medical functions to develop early access programmes for products in your portfolio.
* Act 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 the QA department, manage regulatory activities related to medical devices under Annex XVI of the Medical Device Regulation, ensuring consistency of instructions for use in local languages with the English version and implementation of approved labeling.
Procedures and legislation
* Review global procedures to determine impact on local procedures.
* Write and update local procedures in compliance with local regulation and internal policies.
* Maintain awareness of current and new legislation (EU, BE, LUX, NL for Allergan Aesthetics) and ensure that work is compliant with statutory requirements.
Qualifications
* Scientific, biomedical, or pharmacist degree.
* Several years of regulatory experience or related experience in the pharmaceutical industry.
* Strong meticulousness and good analytical thinking.
* Good communication skills, both verbal and written.
* Organisational skills, managing deadlines and multiple projects efficiently.
* Ability to adapt and thrive in a dynamic environment by managing shifting priorities and responding to changes in regulations and company policies.
* Good collaboration/teamwork mindset.
* Customer‑focused and results‑driven.
* Good Dutch, French and English language skills.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.
#J-18808-Ljbffr