RA Specialist
RAFARM is an innovation-driven, dynamically growing pharmaceutical company and a well-established European manufacturer with an outward-looking orientation, investing 13% of its net turnover in Research and Development. We introduce high technology in our state-of-the-art sterile manufacturing plant and create new production lines with cutting-edge technology and robotic equipment. RAFARM is a place where people evolve, driven by passion and diverse interests. We are a dynamic team that empowers talent, embraces diversity and accelerates development.
About the role
Our Regulatory Affairs Department is growing, and we are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to play a crucial role in ensuring compliance with regulatory requirements and supporting the timely approval of our pharmaceutical products.
The main accountabilities of the role are the following:
- Preparation, compilation, evaluation and submission of the necessary documentation/registration dossiers for Marketing Authorisation Applications, variations and renewals to the competent Health Authorities.
- Lifecycle management of products, including continuous follow-up with Authorities and/or customers related to assigned projects and tasks.
- Direct communication and effective collaboration with other company departments and customers.
- Preparation of product information (SmP
