Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
* Compile and submit the new product registrations, plant registrations, license extensions, variations according to the submission plan, and ensure approvals in a timely manner
* Respond to regulatory authorities’ requirements with satisfies dossier by strict deadlines.
* Maintain and archive regulatory files in a format consistent with requirements.
* Provide regulatory support to internal/external customers.
* Prepare, review, and approve product labeling.
* Able to deliver with tight deadline when needed.
* Manage the routine regulatory affairs operation and special projects.
Education and/or Experience. Include the education and /or experience that is necessary to perform the job satisfactorily
* University Degree or above
* 2-3 years’ regulatory affairs experience in Medical Device or Pharmaceutical Industry preferred.
Qualifications. .
* Ability to manage multiple projects and deadlines
* Good command of English, both writing and speaking
* Written and verbal communication skills
* High level of commitment and initiative