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Galenica s.a. – Regulatory Affairs Associate

Galenica 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.

We are 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 application at contact@galenica.gr and enter the title of the position in the subject.

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