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:
Preparing regulatory submissions (new registrations, renewals, variations) according to the requirements of each country following guidance from Supervisor if required
Communicating with internal and external stakeholders responding to queries and requests with guidance from Supervisor/Head when needed.
Updating departmental databases and reviewing of RIM records to ensure regulatory compliance.
Assessing Change Requests for potential regulatory impact.
Informing all departments when approvals and withdrawals are received, registration/ renewal submissions have been sent.
Compiling and/or preparing dossier sections, updating dossier sections and document versions, ensuring the validity of information to be submitted for all regulatory submissions.
Performing harmonisation of product information leaflet and SmPC with originators with Supervisor's support to ensure all information is up to date; updating packaging materials and information to be country specific should there be such a requirement.
Monitoring regulations and guidelines relating to products and registration procedures, informing the relevant departments when necessary
Assisting in the preparation of departmental documents such as procedures and/or SOPs
Ensuring 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).
Carrying 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 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.
