Project manager regulatory affairs

Funzione Professionale:Varie

Settore:Chimica / Farmaceutica / Healthcare

Tipo di Contratto:Contratto a tempo indeterminato

Azienda:Michael Page

Sede di lavoro:

Nordic Group is a privately owned pan-European pharmaceutical company with a presence in 17 countries. It focuses on the development and commercialization of niche hospital, and orphan products to respond to unmet medical needs. Nordic Group expertise relies on the development and sales of its own products, but also on partner products acquired at various stages of development.
As a Project Manager RA you will work at the Nordic Group office in Baarn, the Netherlands, and mostly focus on the clinical regulatory affairs. You will be responsible for product development, product registration, product maintenance and department related tasks. We are looking for candidates who have strong communication, interpersonal and organizational skills. Do you have a problem-solving approach and experience in project management? Than we might be looking for you! Product development - Role: member project team, representing Regulatory Affairs - Advisory role in technical regulatory aspects of development - (Co-)assessor/author of information/documentation, relevant to the dossier - Develop regulatory strategies for initial MAAs - Co-assessor of the dossier, after compilation Product registration - Role: project manager - Developing regulatory strategies for new products - Responsible for compilation of the dossier - (Co-)assessor/author of information/documentation, relevant to the dossier - (Co-)assessor of the dossier, after compilation - Communication with authorities prior to or during registration procedures (NP, MRP, DCP, CP) - Coordination and preparation of submissions and response documents - Responsible for coordinating other requests from competent authorities and submitting responses Product maintenance - Role: project manager - Developing regulatory strategies for the existing product portfolio - Responsible for the administrative-, clinical- and quality-related product maintenance - Responsible for the preparation and submission of variations and the coordination of the questions and responses - Responsible for monitoring time lines and deadlines Department - Maintenance RA-monitor (screening on regulatory updates) - Maintenance monthly regulatory planning spreadsheets - Maintenance budget: product finance sheet/Synergy invoices - Maintenance of project/product updates and overviews
-Bachelor or Master degree, preferably in life sciences (e.g. Pharmacy, Medicines or Biology) or similar - ⥠5 years of relevant experience in Regulatory Affairs, a clinical RA background is preferred - In-depth registration expertise (NP, MRP, DCP, CP) - Thorough knowledge of the regulatory guidelines - Excellent communication, interpersonal and organizational skills - Accurate, pro-active attitude, autonomous - Strategic and analytic thinking, problem solving - Team player - Flexible and excellent multi-tasking skills - Fluent in English (written and spoken)

La ricerca è rivolta a persone di entrambi i sessi (L.903/77)

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