Regulatory Affairs 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 (SmPC, Labelling & PIL) and review of relevant laws and regulations.
• Registration of medical devices with the National Notified Bodies.
• Monitoring changes in regulatory guidelines, providing recommendations for adopting these changes and ensuring products meet legislative requirements.
• Maintaining and updating the department’s regulatory database for assigned projects.

Requirements

• BSc in chemistry, biology, pharmaceutical science, chemical engineering or other relevant disciplines.
• 2-3 years of regulatory experience in similar position in the pharmaceutical sector.
• Excellent knowledge of English, both written and oral.
• Ability to cope with strict timelines and work on tight deadlines. Planning and time management.
• Ability to work effectively in team environment, both independently and as a team player with a positive attitude.
• Highly detail-oriented and organized. A methodical mind with strong problem solving abilities.
• Communication and negotiations skills.
• Excellent knowledge of MS Office and e-CTD submission.

Benefits

• Competitive compensation
• Private health insurance
• Career development opportunities
• Work-life balance
• Company transportation
• Innovative work environment
• Community engagement
• Recognition and rewards

Why Join Us
At RAFARM, you will be part of a passionate team dedicated to making a positive impact on global health. You will grow your career in a dynamic and innovative environment where your contributions truly matter.

How to Apply
If you believe that the above position suits you, we look forward to receiving your application. Please submit your resume here.
Following the evaluation of all CVs, only candidates who meet the requirements of the position will be contacted to schedule an interview. All applications are treated with strict confidentiality.