Galenica SA is NOW HIRING - Regulatory Affairs Associate

Galenica SA is one of the largest Greek pharmaceutical companies which promotes research and serves health with consistency and scientific responsibility, by developing high-quality and innovative pharmaceutical products.

Galenica SA is currently looking for a Regulatory Affairs Associate.

Main Duties and Responsibilities

• Prepare and submit Marketing Authorization applications, variations, renewals, withdrawals and transfers of Marketing Authorizations
• Maintenance of the Lifecycle of the products
• Product Submissions to Medicines Agencies of EU & other countries
• Cooperation with the company's manufacturing site as well as with the R&D department for the registration/variations of the products.
• Prepare and submit answers to Deficiency Letters received from the Health Authorities
• Perform translations of the Summaries of Product Characteristics, Patient Information Leaflets and Labelling
• Review of the packaging materials to ensure full compliance
• Liaise closely with Health Authorities
• Ensure that deadlines are met

Qualifications

• Bachelor’s degree in Life Sciences (Pharmacy, Chemistry, Biology)
• 3-5 years of experience in the Regulatory Field
• Knowledge of GMP’s and Pharmaceutical Legislation
• Excellent computer skills especially Word and Excel
• Fluency in English (writing, reading, speaking)
• Laboratory experience will be considered an asset

Please send your CV at contact@galenica.gr and enter the title of the position in the subject.