Regulatory Affairs Specialist - București, România - ADDENDA PHARMACEUTICALS S.R.L.

Descriere

Job Responsibilities:

Support with maximum efficiency in the operational management of the documentation preparation of the new registrations / renewals / line extensions/ variations, submission for medicines, food supplements and medical devices.

Provides support to Regulatory Affairs Manager in the documentation preparation for launching plan, planning of variations, implementation of changes on the market, discontinuation of marketed products.

Provides support to Regulatory Affairs Manager in reports (daily, weekly, monthly, yearly).
Support with maximum efficiency in the operational management of the preparation of the specific.

Romanian packaging items, ensures that the approved texts are promptly sent to the plants and that the final validation is given in accordance with the approvals obtained.

Performs English Romanian/Romanian English translation of PILs, SmPCs and other Regulatory documents assigned by Regulatory Affairs Manager

Supports Regulatory Affairs Manager in checking and validating Regulatory compliance of promotional activities in line with local regulations and company guidelines and standards.

Maintains accurate records of all ongoing/closed regulatory procedures and prepares a monthly report.
Fulfill any task assigned by the direct supervisor (Regulatory Affairs Manager).
Provides support to Regulatory Affairs Manager in pricing submissions and in preparing the documentation and internal uploading.
Supports Regulatory Affairs Manager in local Regulatory SOPs update.

The role is hybrid, the percentage of office-based activity is established in line with internal policies and direct supervision decision.

Candidatul ideal

We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs Department, to support the Regulatory Affairs team with all administrative/reporting workflows and assist them during the process of obtaining and maintaining government approvals for the company's products.

Job Profile:
University degree. University Degree in Pharmacy/ Chemistry/Biology will be an advantage.
Previous experience in the pharmaceutical industry will be considered an advantage.
Proven background in documents management activities (contracts, legal documents, submission files for public authorities etc.).

Computer literacy:
Advanced knowledge of Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook.
Advanced competencies in written communication (Romanian and English).
Strong skills in teamwork and collaboration.
Details orientation and ability to work for more projects, simultaneously.
Proactive and positive attitude.