Main responsibilities and activities
In the Regulatory Department we are looking for a brilliant profile reporting to the Regulatory Affairs Senior Manager with the following responsibilities and activities:
Main responsibilities
Manages the regulatory aspects and related tasks of the assigned commercial APIs.
Performs activities, while keeping the knowledge up to date, based on Teva policy and guidelines of the international Regulatory Authorities.
Proactively collaborates with the Regulatory Administrative team members, which release and submit the finalized API’s dossier or documentation.
Main activities
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.
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.
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 help solving technical or commercial issues.
Requirements
Education:
Minimum: University Scientific Degree.
Preferred: Specialty in Chemistry, Industrial Chemistry and Pharmaceutical Technologies.
Experience:
Minimum: 3 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 and Italian Language: good professional level, both in writing and speaking.
