Regulatory Affairs Manager International / Leiden
Deze vacature staat offline! |
| De opdrachtgever
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Pharmaceutical company in Leiden
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| De omschrijving
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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.
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| De eisen
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- 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.
- Preferably good knowledge of the regulatory rules, guidances and institutes in the territory
- Fluent in English, both spoken and written.
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| De arbeidsvoorwaarden
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- A challenging and diversified job
- Good career opportunities
- Inspiring work climate
- Attractive remuneration.
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| Contactinformatie
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Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Arjan van den Wijngaard
Consultant Medical
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
mobiel 06 50650550 |
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