Operating for almost two decades in Greece and Cyprus, CORONIS has been delivering a full spectrum of services to national and international pharmaceutical, biotechnology and medical device industries and other healthcare-related organisations. As a Contract Research Organization (CRO), CORONIS wishes to contribute in the delivery of life-changing therapies to patients worldwide.
Currently we are looking for a Regulatory Affairs Associate to join our team!
The Regulatory Affairs Associate is responsible for accomplishing the regulatory affairs activities relating to clients’ products (Medicines, Medical Devices, Cosmetics, Food Supplements and Chemical Products), as assigned by the Regulatory Affairs Manager.
Primary responsibilities:
- Monitor local and EU legislation, guidelines, and practices to ensure that company’s regulatory intelligence library is up to date
- Support the preparation and submission of New Drug Applications (CTD) through Centralized (CP) and Mutual Recognition Procedures (MRP) and National Procedures (MAA)
- Support the maintenance of Marketing Authorization Applications (Variations and Renewals) abiding to post approval commitments, as well as handling of withdrawals and transfers of Marketing Authorizations
- Review materials (including but not limited to SmPC, labelling, PIL, IFU, or marketing/promotional material) in accordance to EU and local legislation, to ensure regulatory compliance
- Registration of medical devices to the National/European database and support the preparation/maintenance of technical dossier for CE mark
- Support pricing and reimbursement activities
- Liaise closely with the Health Authorities and ensuring the optimum relationship between the regulatory authorities and our customers
Qualifications:
- University degree in life sciences, pharmacology or chemistry
- At least 1 year of previous demonstrated experience in the regulatory field
- Excellent command (written and verbal) of English language and proficient knowledge of medical terminology
- IT literacy (MS Windows, MS Office, Internet Use)
- Solid understanding of the drug development process, pharmaceutical legislation and scientific matters
- Ability to interact professionally with customers and work effectively within a team
- Ability to manage multiple and varied tasks with attention to detail
- Effective time management to ensure project deadlines are met
- Ability to work independently with regular oversight and open to seeking guidance when necessary
If you fulfill the requirements of this position and you’re interested in joining our team, please send your CV to: careers@coronis.gr
