Full-Time Regulatory Affairs Associate
COMAC MEDICAL is a Full Service CRO/SMO providing a broad network of clinical research sites in the best healthcare institutions across Central and Eastern Europe. Due to our successful development, we are looking for our new projects in Hungary for highly motivated and responsible candidates for the position of:
Regulatory Affairs Associate
- Establish study submission strategy with client and project team;
- Discuss and agree the submission timelines with the client and observe meeting the established timelines;
- 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;
- Assist in resolving issues related to submission process and requirements;
- When required, communicate and submit study documentation to Regulatory Authorities and Ethics Committee and follow-up on any requests, comments and/ or issues;
- Initiate and participate in internal discussions for any regulatory requirements and issues;
- Consult and provide national regulatory information requested by clients and keep relevant records;
- As per the established agreement with the client, perform Initial Document Compliance (IDC) review regarding particular clinical trial following company or client SOP;
- Collect for new or updated national/ international regulation framework;
- Provide regular reports as required;
- Maintain regulatory database.
- University degree;
- At least 1 year experience in the field of clinical trials;
- Excellent knowledge of ICH GCP and applicable national regulations regarding Clinical Trial Application (CTA) and other clinical research related procedures;
- Good command of spoken and written English;
- Computer literacy;
- Strong communication skills and ability of teamwork;
- Ability to work under pressure and to keep tight deadlines.
The Company Offer:
- Job-specific training;
- Work for a successful international company, excellent career development opportunity in a perspective professional field;
- Competitive and result orientated remuneration;
- Additional benefits related to work performance.
The Assigned Country: Hungary
How to ApplyIf you are interested in such an opportunity please send your CV and a cover letter in English describing why your experience and skills make you a good candidate for this position to firstname.lastname@example.org. Only short listed candidates with enclosed cover letter will be contacted for interviews.
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