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Regulatory Affairs Director

vor 2 Monaten


Essen, Nordrhein-Westfalen, Deutschland Advanced Resource Managers Vollzeit

Regulatory Affairs Role Overview

Advanced Resource Managers is seeking a highly skilled Regulatory Affairs professional to join our team in Germany. As an Associate Director of Regulatory Affairs, you will play a key role in preparing, reviewing, and coordinating regulatory submissions under the new EU CTR process.

Key Responsibilities

* Provide guidance on local regulatory strategy and advice to various sponsors
* Serve as the key-contact at country level for ethical or regulatory submission-related activities
* Collaborate with the clinical team to prepare regulatory compliance review packages
* Ensure local country study files and filing processes are prepared

Requirements

* Bachelor's degree
* 5+ years of clinical experience or equivalent combination of education, training, and experience
* Excellent oral and written communication skills
* Strong interpersonal skills
* Basic medical/therapeutic area and medical terminology knowledge
* Familiarity with regional/national country regulatory guidelines and EC regulations

If you are interested in this opportunity, please contact us for more details.