ELPEN Pharmaceutical Co. Inc., a Greek Pharmaceutical Company, is seeking a Regulatory Affairs Officer/ EU
Job Description
As a Regulatory Affairs Officer you will be responsible for handling and supporting Regulatory Affairs processes in EU excluding Greece, as part of the Regulatory Affairs team. You will report directly to the Regulatory Affairs Senior Manager/ EU and Regulatory Affairs Director and align and collaborate with third party Organizations, EU Health Authorities as well as various departments within the Company.
Main Duties and Responsibilities:
- Liaise with EU Regulatory Authorities
- Liaise with various departments within the Company in order to collect all information and documentation necessary for the preparation of regulatory submissions
- Liaise with Partner companies/third parties
- Prepare and submit MAAs, variations, renewals in a timely manner and as per the agreed Regulatory Strategy
- Monitor & implement the EU Pharmaceutical legislation with regards to products registration
- Ensure regulatory compliance of registered products
- Prepare and submit e-CTD files
- Maintain Internal Data Management Systems
Minimum requirements
- Bachelor Degree in Pharmacy, Biology, Chemistry or other related field
- Minimum 2 years of experience in similar position in the pharmaceutical industry
- Knowledge of EU Pharmaceutical legislation with regards to products registration
- Strong verbal and written communication skills. Able to communicate in an effective manner with other departments and work as part of a cross functional team
- Fluent in English, both in verbal and written communication
- Very good knowledge of CTD structure and e-CTD programme
- Strong organization and computer skills
If you want to apply for this position please send your CV to the email hr-ra@elpen.gr with the indication “RA04”.
