Regulatory Start Up Associate II UK

Job Description

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 UK. The suitable candidate shall have desire to develop in Regulatory activities and specialize with the time in Regulatory submissions and requirements for UK.

Minimum Qualifications & Experience:

• Excellent written and oral communication skills in English
• 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

Job Responsibilities:

• Participates in all activities leading to investigational sites activation
• Provides interpretative assistance of guidance documents and regulatory rules applicable for UK 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.

About Us

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices acrossAsia-Pacific,North America, andEurope. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.