Regulatory Affairs Manager (m/w/d)
Our experts at Randstad professional solutions are looking for an experienced freelance Regulatory Affairs Specialist, who supports our customer's team in preparing and submitting approval dossiers and compliance with regulatory requirements. Apply now! JOBV1_EN
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Your tasks • Your profile • What we offer
Our experts at Randstad professional solutions are looking for an experienced freelance Regulatory Affairs Specialist, who supports our customer's team in preparing and submitting approval dossiers and compliance with regulatory requirements. Apply now!
Creation of approval dossiers: coordination and compilation of approval documents (e.g. according to the Common Technical Document (CTD) format) for medicines and medical devices Authorities communication: Contact for national and international health authorities (e.g. EMA, FDA) and processing of inquiries Regulatory Strategy: Development and Implementation of Approval Strategies for New Products Maintenance of authorisations: implementation of change indications and extensions of existing authorisations Compliance monitoring: ongoing review of compliance with regulatory requirements and regulatory changes
Graduate in pharmacy, biology, medicine or related discipline Multiannual professional experience in Regulatory Affairs, ideally in the pharmaceutical environment Knowledge of regulatory requirements for medicines and/or medical devices (EU, USA, etc.) Experience in the creation of approval dossiers (CTD) Sovereign communication skills and negotiation skills
Attractive possibilities to shorten your personal payment destination No more time-consuming billing required Fast, reliable fee payment Complete project contracts with electronic signature JOBV1_EN
Company location
Location
 | Randstad Deutschland GmbH & Co. KG | |
| 37115 Berlin | ||
| Germany |
The text of this ad was translated from German into English using an automatic translation system and may contain semantic and lexical errors. Therefore, it should be used for introductory purposes only. For more detailed information, see the original text of the ad at the link below.
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