Beschreibung
Requirements / Tasks:- Focusing on pharmaceutical regulatory submission
- Preparation and submission of new applications for authorization of pharmaceuticals in Asia Pacific Countries and ensure that the appropriate regulatory activities are ongoing
- Support development of regulatory documentation for the local countries according to the respective regulatory requirements and also in accordance with the internal requirements
- Coordination and management of the receipt, distribution and timely answers to queries authorities in the framework of the projects within the jurisdiction, together with responsible person from R&D, CMC and/or other departments
- Preparation of regulatory strategies for the required APAC countries with respect to registrations and/or coordination of thec ollection of the relevant regulatory requirements and guidelines for the respective countries
- Regular tracking of submission status in the responsible countries, together with the respective local regulatory person or partners
Requirements:
- at least 3+ years experience in Regulatory Affairs
- experience with Regulatory processes within the APAC region (major countries e.g. Japan, China, Taiwan)
- English: fluent
- German: optional
Details:
- Start Date: ASAP
- Duration: 6 months (at least)
- Volume: 100% (40h / week)
- Area: Hessen, on site
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