Regulatory Affairs Specialist

BalkanTrials is an established service provider of Clinical Development Services to the global bio-pharmaceutical industry, internationally recognized for its top quality, driven by superior medical and ethical standards.

Regulatory Affairs Specialist
Location: Sofia

Main responsibilities:
• Supports the operation of the company quality model and the defined quality assurance processes;
• Contributes to the delivery of quality reviews and quality enhancement activities;
• Provides day-to-day support to the Team Leaders to resolve questions and issues related to quality;
• Participates in weekly updates and business reviews between clients and the extended teams;
• Supports induction training for new team members;
• Provides trends analysis, gives regular reports;
• Reviews the systems related to the conduct of clinical trials and reports to the senior management;
• Helps our clients to ensure the integrity of their clinical trials;
• Ensure adherence to protocols and international regulatory guidelines;
• Helps clients to protect research subjects' rights and welfare;
• Enforces compliance with local, national and international regulations, standards and guidelines;
• Assesses all conducted clinical trials for compliance with applicable regulations and procedures, and adherence to the protocol/s;
• Reviews protocols and case report forms;
• Audits internal study files, audits data review and computer entries;
• Participates in audits at the company offices and at sites of the clinical studies.

Background/Requirements:
- minimum 2 years’ experience in a Clinical QA department in pharmaceutical company / CRO
- life sciences degree, medical /veterinarian/pharmaceutical degree
- excellent command of written and spoken English
- fluency in Bulgarian

Compensations and Benefits:
- competitive salary
- bonus opportunities
- intensive initial training
- continuous education and assessment
- genuine career development potential

We offer:
- a team of motivated young professionals led by very experienced managers
- friendly working environment in central Sofia

Please, present your resume in English with a recent business photograph and anonymized list of trial experience as a Microsoft Word document with the following file name grammar: LastName_FirstName_DDMMM in which DDMMM is your birthday.

https://www.jobs.bg/job/4561401