Regulatory Affairs Officer

Excelya>Full-time>Regulatory Affairs Officer

Job description

EXCELYA, the fastest growing European CRO with presence on 26 countries across Europe, expands its team and is looking for an experienced Regulatory Affairs Officer to join our team in Greece.

Are you ready to make your next career step and join EXCELYA on its way to become the Leading CRO in Europe?

Purpose of the role:

The mission of Regulatory Affairs Officer is to ensure the licensing, marketing and legal compliance of medicinal and related products. Working as part of our Regulatory Affairs team, you will be responsible for:

  • Keep up to date with local and EU legislation, guidelines and practices
  • Prepare and submit Marketing Authorization applications, variations, renewals, withdrawals and transfers of Marketing Authorizations
  • Support in preparation and submission of answers to Deficiency Letters (DLs) of Health Authorities
  • Perform high quality translations of the Summaries of Product Characteristics, Labeling and Patient Leaflet
  • Regulatory review of packaging & promotional material to ensure fully compliance
  • Support in the provision of regulatory intelligence
  • Liaise closely with Health Authorities

Join us for a challenging career!

The company offers a competitive remuneration package, as well as continuous development and career opportunities in an exciting, international and supporting working environment.

At EXCELYA your career will flourish, as we care about what you can be and how fast you can reach higher international positions.

Profile:

  • University Degree in Life Sciences, a post graduate diploma in relevant field will be considered an asset
  • Previous experience of at least 2 – 3 years in the regulatory affairs field and proven understanding of local and EU regulatory requirements is required.
  • Strong critical thinking & ability of data interpretation
  • Ability to multi-task, prioritize, keep deadlines and operate promptly and efficiently under pressure in a demanding multinational environment
  • Goal and results’ orientation
  • Attention to detail as well as analytical and problem-solving skills
  • Advanced communication skills, team orientation, ability to successfully convey messages
  • Excellent command of the Greek and English languages (both verbally and written)
  • Very Good knowledge of MS Office

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