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
- 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 firstname.lastname@example.org and enter the title of the position in the subject.