About the job
RAFARM is a forward-thinking and rapidly expanding pharmaceutical company, recognized as a prominent European manufacturer with a global perspective. We allocate 13% of our net turnover to Research and Development, fostering innovation in our state-of-the-art sterile manufacturing facility. With advanced technology and robotic systems, we are constantly developing new production lines. At RAFARM, we cultivate an environment where individuals can grow, driven by passion and diverse interests. Our dynamic team is dedicated to empowering talent, celebrating diversity, and accelerating professional development.
About the Role
As our Regulatory Affairs Department continues to expand, we are looking for a proactive and meticulous Regulatory Affairs Specialist. This role is essential in ensuring our pharmaceutical products meet all regulatory standards and receive timely approvals.
Key Responsibilities:
- Prepare, compile, evaluate, and submit necessary documentation and registration dossiers for Marketing Authorisation Applications, variations, and renewals to relevant Health Authorities.
- Manage the product lifecycle, including ongoing communication with Authorities and/or customers regarding assigned projects and tasks.
- Facilitate direct communication and collaboration with various company departments and clients.
- Prepare product information (SmPC, Labelling & PIL) and ensure compliance with relevant laws and regulations.
- Register medical devices with National Notified Bodies.
- Monitor changes in regulatory guidelines, provide recommendations for adaptations, and ensure products comply with legal requirements.
- Maintain and update the department’s regulatory database for assigned projects.