Maintain up to date the various dossiers filed to the relevant regulatory Authorities, by submission of DMF amendments or total updates in a suitable format, while managing the upgrade of the technical content of the file, according to the available information. Works independently with minimal guidance and contributes to process improvements.
In order to improve the business in the new markets, develop a dossier in line with Teva policy and in compliance with the local Authority requirements.
Reply to additional information requests from Health Authorities (clarification or lack of information on the technical content of the file), while proactively interfacing with the relevant departments, in order to collect and elaborate appropriate answers to the questions raised. Takes a new perspective using existing solutions.
Support customers as a RA assignee of Service Requests, giving relevant information with professional answers.
Participate, if needed, to internal meetings (with production, QA, QC and R&D) or conferences with customers or marketing staff, in order to support solving technical or commercial issues.
Provides informal guidance to junior staff, support the team in-depth knowledge and experience.
Minimum: University Scientific Degree
Preferred: Specialty in Chemistry, Industrial Chemistry and Pharmaceutical Technologies.
Minimum: 5 years work experience in Regulatory in a fine chemical industry. Working experience in Quality and R&D will be also considered as a plus.
English Language: good professional level, both in writing and speaking.