ABOUT US:
We are dedicated to the research, design, validation, manufacture and distribution of anti-allergic vaccines (immunotherapy sector).
We have a Technical, R&D and Clinical Trial headquarters in Zamudio, our only production centre for the moment. In this sense, we have a strong growth forecast.
Our value proposition for employees is as follows:
- PEOPLE-CENTRIC: We focus on people.
- SELF-DEMANDING PEOPLE: We promote individual self-demand in pursuit of common achievement.
- CURIOUS PEOPLE: We learn by innovating, valuing the experience that each person can bring to the organisation.
ABOUT THE JOB:
Due to increased workload, we are looking for Regulatory Technician to develop with us. You will report to the Head of the Regulatory Unit within the Technical Directorate.
Mission. To apply for the registration of new drugs and maintenance of the dossiers according to the requirements of the regulatory authorities, to the existing legal rules and to the guidelines and goals set by the Company.
Main tasks and Responsibilities:
- To prepare, coordinate and submit the dossiers for allergenic vaccines and diagnostics in accordance with the existing legislation.
- To ensure the maintenance of the regulatory status of allergenic vaccines and diagnose to the legal authorities in accordance with the existing legislation.
- To manage the strategy of submitting the dossiers and their variations.
- To answer the regulatory authorities of the suggested deviations of the dossiers.
- To build up eCTD dossiers according to requirements for each country.
- To update and distribute the national and international legislation for the immunotherapy products.
Requirements:
- Master’s degree in Biosciences / Pharmacy.
- Professional experience of 2 years in similar positions.
- Knowlegde in English language (spoken and written, minimum B2 or similar ).
- Knowlegde in computers.
Remuneration: according to Company Agreement ( Category 6th Chemical Collective Agreement ).
Observations: We are looking for a creative and achievement-oriented technician, with a firm but empathetic leadership style, used to developing relationship models based on trust within his team and to work transversally with the rest of the areas.
