Work schedule
standard (mon-fri)
environmental conditions
office
job description in this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (phase 1 to 4) clinical trials, studies and projects.
You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance.
You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients.
You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings.
The following skills are required to be successful in this position:
preparation and assembly of global regulatory submissions
interacting with sponsors,
review and assess clinical trial regulatory documents,
review and assess scientific literature.
Manages project teams and preparation
participate in launch meetings, review meetings and project team meetings.
Optional skills:
experience with bid defense meetings
qualifications - external
what the role requires you to have:
bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
previous experience that provides the knowledge, skills, and abilities to perform the job
knowledge of the global clinical trials landscape
knowledge, skills and abilities:
excellent command of the english language (written and oral) as well as local language where applicable
exce