Regulatory Affairs Specialist


The Position:
• Establish study regulatory strategy with client and project team;
• Discuss and agree on the submission timelines with the Project Leader and the client;
• Perform quality check of clinical trial documentation prior to EC and RA submission as per the local requirements and SOP in close collaboration with the study team;
• Initiate and participate in internal discussions for regulatory requirements and issues;
• Reviews project documents for regulatory completeness, consistency, and accuracy, interacts with project team members to assure completeness, as necessary;
• Support Global Regulatory Affairs Manager in the determination of regulatory strategy/expectations and parameters for submissions and all necessary authorizations, as requested;
• Support Global Regulatory Affairs Manager in implementation of the regulatory changes;
• Support the Global Regulatory Affairs Manager in developing a strategy for ensuring regulatory intelligence, as needed;

The person:
• Graduate or postgraduate degree;
• At least 1-year experience in regulatory activities with regards to the clinical research;
• Working knowledge of current ICH/GCP guidelines, applicable regulations (including country-specific ones), and current industry practices;
• Excellent organizational, communication (verbal and written) and interpersonal skills;
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings;
• Positive attitude and ability to interact with all levels of staff;
• Ability to work under pressure and to keep tight deadlines;
• Proficiency in English;
• Working knowledge of Word, Excel, and PowerPoint;

Arsis Global EOOD's Bulgarian recruitment agency license (mediation in employment services) number is 2533 and was issued on 11.05.2018.

Note, that we will contact only those candidates who qualify for the position, in case you don't hear from us by 30th of June, this would mean that your application was unsuccessful in this occasion. Thank you for your application.

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