Vacature Regulatory Affairs Manager - Office based in Zuid-Holland
Functie: Regulatory Affairs Manager
Regio: Zuid-Holland
Bedrijfomschrijving
The company is one of the top 20 pharmaceutical companies in the world, employing 14,000 people globally. As a young and forward-thinking company, she is dedicated to improving the lives of people around the world through the introduction of innovative and reliable pharmaceutical products. The location in the Netherlands is home to the European R&D organization focusing on the development of medicines in the areas of Pain, Urology and Diabetes/Metabolic diseases. An R&D investment budget of 15-20% is evidence of the company's commitment to improving the health of people worldwide through the provision of innovative and reliable products. It is also the head office for the Dutch affiliate.
Functieomschrijving
For the International Marketing & Sales organization of this company, we are looking for a Regulatory Affairs Manager. In this role you are responsible for preparing, composing, submitting, defending and coordinating Marketing Authorization Applications (MAA) files and its belonging variations, renewals and other submissions in close cooperation with Regulatory Affairs Europe and the representing agent Regulatory Affairs contact. You will participate in regular cross Sectional meetings in Regulatory Affairs, meetings with the management of the relevant region(s) of the International Department and meetings with the representing agents. You will assess registration activities for relevant products in relevant regions by preparing a Regulatory International Plan and ensure register ability and maintenance of existing registrations.
Functie-eisen
The qualities of the Regulatory Affairs Manager include:
- Success-driven, Team-oriented, Adaptable and Respectful
- Academic qualifications preferably as a pharmacist, chemist or (medical) biologist
- At least 2-3 years experience with regulatory affairs activities in the pharmaceutical industry
- Experience in working in multidisciplinary teams
- Good communication and writing skills
- Accuracy Good organisation/co-ordination of work in a complex setting
- Preferably good knowledge of the regulatory rules, guidances and institutes in the territory
- Fluent in English language, both spoken and written
- Preferably fluent in Arabic language, both spoken and written
The company offers:
- A challenging and diversified job
- Good career opportunities
- Inspiring work climate, in a truly international environment
- Attractive remuneration.
Solliciteren
Heb jij interesse in deze functie als Regulatory Affairs Manager voor Zuid-Holland?
Neem dan contact op met Irene Houtsma 
via onderstaande sollicatie knop of bel naar 038-455 62 62..
