Regulatory affairs officer
ManpowerGroup Solutions: pleased to meet you
Back in the past, the most important asset was capital. Today, however, in the ‘Human Age’, the most important asset is human talent. Talent is the only real driver of economic growth and development. Attracting, stimulating and developing this talent is the biggest challenge for any company seeking to set itself apart from the rest. It is a challenge that ManpowerGroup Solutions accepts with relish.
Expertise. Innovation. Results.
ManpowerGroup Solutions delivers result-driven solutions and services based on human talent. We can respond to the immense challenges that our clients face every day. We match human talent to our clients’ ambitions, to provide results that matter. Using our local and international contacts and skills, we deliver comprehensive, innovative solutions based on cooperation and hands-on creativity.
The leading global HR expert
ManpowerGroup Solutions is part of ManpowerGroup, one of the world’s leading HR companies. With branches in 82 countries, 30,000 employees and 400,000 clients, we put 348 people to work across the world….every minute! We continuously provide innovative solutions for the world of work.
For more information, please see www.manpowergroup.be
For one of our customers, active in the pharma sector in Beerse, we are looking for a
Regulatory Affairs Officer.
You will be responsible for the management and delivery of regulatory submissions to global health authorities required to support the maintenance, development and registration of products.
• You will establish Dossier Plans for the assigned Global submission types as needed to support the lifecycle of one or more products.
• You will be responsible for: generating dossier plans that will reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
• You will ensure relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
• You will dispatch/distribute in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
• You will support development of departmental work practices, process enhancements, and associated training materials.
• You will develop/maintain associated process tools and relevant training documentation.
• You will apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements; Maintain open, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission; Participate on special projects and process improvement initiatives, as needed.
• You have a bachelor’s degree or an equivalent experience
• You have at least 6 years of Regulatory Affairs experience
• You have experience associated with managing or publishing of global regulatory submissions, including FDA (eCTD) and/or EMA (National, MRP and CTAs)
• You have by preference knowledge of the therapeutic area and product, an understanding of drug development process
• You have by preference capabilities with project or submission
• You are a team player
• You have strong communication a problem-solving skill
• You can work in a matrix environment
• You can use Regulatory Information system
• You are fluent in English
• A contract of undetermined duration with Manpowergroup Solutions
• An interesting salary package with extralegal advantages (meal vouchers, group and hospitalization insurance)
• The opportunity to work in a challenging environment and real opportunities for individual growth
Please send your CV to Laure.email@example.com