Company Description

About AbbVie

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. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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 affairsManage 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 needCollaborate with Medical functions to develop early access programs for the products in your portfolioActs 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 proceduresWrite and update local procedures in compliance with the local regulation and internal policies and procedures, if applicableMaintain awareness of current and new legislation (EU, BE, LUX, NL for Allergan Aesthetics) and ensure that work is in compliance with the statutory requirements
Qualifications

Required Education / Knowledge / Experience

Scientific degree/Biomedical degree/PharmacistSeveral years of Regulatory experience or in a related area in pharma industryStrong meticulousness, good analytical thinkingGood communication skills, both verbal and writtenOrganizational skills, managing deadlines, multiple projects, and documentation efficientlyAbility 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 mindsetCustomer-focused and results-drivenGood Dutch, French and English language skills
Additional Information

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/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html