Prepares, review and coordinates submissions in alignment with global submission strategy.
Provides strategy advice to clients.
Develops and implements local submission strategy.
Serves as primary contact for investigators and with the local authorities (in collaboration with the local regulatory manager for sophisticated issues) to ensure submissions are managed in a timely manner.
Ensures guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.

Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years).