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description de la société
Do you believe in affordable healthcare? Are quality & safety your priority number 1? Then you'll feel comfortable in this company, who's one of the biggest pharmaceutical companies in the world.
Do you want to be responsible for the management and delivery of regulatory submissions to global health authorities required to support the maintenance, development and registration of products? Mail your up-to-date resume to email@example.com or call 03 369 19 80.
description de la fonction
Are you the regulatory affairs specialist that wants to be responsible for the management and delivery of regulatory submissions to global health authorities required to support the maintenance, development and registration of products? Then this is your next challenge!
You meet regularly with submission stakeholders and area representatives tocreate dossier plans, identify and resolve issues and asses the quality of deliverables and timelines.
You ensure relevant submission process(es) are applied to all assigned submissions.
You make sure that the dispatch/distribution is in compliance with due dates to Health Authorities and/or Local Operating Companies.
You track submission events/activities in appropriate system/tools.
You support the development of departmental work practices, process enhancements and associated training materials.
You maintain open, timely and effective communications with all publishing contributors and the responsibleRA professional to ensure timely delivery.
You participate on special projects and process improvement initiatives.
You have a bachelor degree or equivalent by experience.
A minimum of 6 years of professional experience is required with 3 years of Regulatory Affairs experience (managing or publishing of global regulatory submissions).
Your project or submission management capabilities gives your application an edge.
You have knowledge of relevant submission-related Health Authority and Industry regulations and guidelines.
You are a strong communicator on all levels which helps you in building productive relationships.
Your interpersonal and communication skills, eye for detail and accuracy will convince the hiring manager to choose you as his next colleague!
As an answer to your high performance & flexibility, AUSY offers you an interesting salary package, with some interesting extra's like:
Meal vouchers of €7
Net representation cost of €50
Car + unlimited fuel card OR home-work compensation
Opportunities to follow trainings
And on top of this you'll improve your RA skills and become an even bigger expert!