As a Regulatory Specialist you will be expected to assist in regulatory submissions of clinical trial applications and support Clinical Research Associate activities at the study start and perform other administrative duties as assigned by management. We are searching for a positive and energetic person, eager to learn, push forward administrative processing of the documents and function well in the project team. Reporting to Regulatory Manager, you will be a key member of the Regulatory Affairs department in Romania. The suitable candidate shall have desire to develop in Regulatory activities and specialize with the time in Regulatory submissions and requirements for Romania.

MINIMUM QUALIFICATIONS & EXPERIENCE:

• Excellent written and oral communication skills in English and Romanian
• Flexibility, adjustability, initiativeness
• Open to learn new things and communicate across countries and cultures
• Independence in work
• Previous experience in clinical research field is an advantage
• Background of natural science is an advantage
• Position is highly suitable for Study Coordinators

• Participates in all activities leading to investigational sites activation
• Provides interpretative assistance of guidance documents and regulatory rules applicable for Romania and ensures their communication through company policies and procedures
• Customize Patient Information Sheet and Informed Consent Form at country level
• Prepares submission packages in cooperation with global team and upload document to CTIS for Part II
• Takes part in the communication with Regulatory Authorities and Ethics Committees
• Provides training and support to CRAs in order to collect all necessarily documents for start up package and IP release
• Close collaboration with Regulatory Lead and Project Team during entire project
• Performs tasks according to relevant SOPs and completes the SOPs training in given timelines
  Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
  Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
  We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
  We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application