Job Title: Senior Regulatory Expert
Required Skills and Qualifications:
* Develop project management expectations across projects.
* Communicate submission tracking requirements to both internal teams and external partners.
* Lead CMC submission management processes, prepare CTD content consistent with approved manufacturing changes.
* Implement and interpret global regulations and guidance into submission processes.
* Possess a strong working knowledge of internal procedures, regulatory precedence, and electronic submission regulations.
* Have experience in drug development or industry-related experience.
* Be able to operate and manage operational requirements in a regulated environment.
Benefits:
We offer a premium workspace, flexible hybrid working options, healthcare benefits, pension and life assurance benefits, and more.
Others:
We are committed to diversity, equity and inclusion (DEI) and cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender.