Remedica is a leading pharmaceutical company located in Cyprus with pharmaceutical products being distributed in more than 140+ countries worldwide. Originally founded in 1980, it went through various development stages. Today Remedica is specialising in the development, production, and sale of high-quality, safe, and efficacious pharmaceutical products for human use. Our pharmaceutical range consists of a product portfolio of more than 300 generic, branded generic, and over-the-counter (OTC).

Over the last few years, Remedica went through a massive transformational program from a locally recognized reputable company to a global player, respected by its distributors, partners, and clients. The investments into the factories, R&D equipment, new facilities, implementation of best-in-class software, and people development are the baselines for Remedica's success in the future.

We are looking for:
A Junior Regulatory Affairs Officer to join our dynamic team to act as the link between Remedica and regulatory authorities, providing the necessary documentation in order to obtain and/or maintain existing marketing authorizations and ensuring Remedica’s regulatory compliance.

As a Junior RA Officer you will:

• Prepare regulatory submissions (new registrations, renewals, variations) according to the requirements of each country following guidance from Supervisor when needed.
• Communicate with internal and external stakeholders responding to queries and requests with guidance from Supervisor/Head when needed.
• Update departmental databases and review RIM records to ensure regulatory compliance.
• Assess Change Requests for potential regulatory impact.
• Inform departments when registration/ renewal submissions have been sent and when approvals are received.
• Prepare and/or update dossier sections, ensuring the validity of information for all regulatory submissions.
• Perform harmonisation of product information (leaflet and SmPC) with the originator product and update of packaging materials.
• Monitore regulations and guidelines relating to products and registration procedures, and inform the relevant departments when necessary.
• Assist in the preparation of departmental documents such as SOPs.
• Ensure that tasks and processes are executed according to established regulations and guidelines such as Standard Operating Procedures (SOPs), and the current Good Manufacturing Practices (cGMP).
• Carry out any other duties as assigned by Supervisor/Head and/or Deputy RA Manager/RA Manager.

What you will bring:

• University degree in Pharmacy, Pharmacology, Biology or relevant field.
• Previous relevant experience in the field of Regulatory Affairs or in the pharmaceutical industry will be considered as an advantage.
• Very good knowledge of English language.
• Strong analytical, communication, organizational skills.
• Computer literacy. 

Why Join Remedica? At Remedica, we offer a competitive compensation package, including 14 salaries, a provident fund, and a range of additional benefits to support your personal and professional growth. Join our team and be part of a company that values innovation, teamwork, and continuous improvement.