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Pharmaceutical Regulatory Expert

3 weeks ago

Copenhagen, Copenhagen, Denmark Hurecon Full time
About the Job
We are seeking an experienced Regulatory Affairs professional to join our team in Copenhagen. As a key member of our regulatory department, you will be responsible for maintaining and following up on global Marketing Authorizations on the European Market. This includes managing a product's lifecycle from application submission to national package level in collaboration with different contact persons. You will also serve as a procedural contact person to authorities, preparing administrative sections and communicating with National Competent Authorities and company customers on behalf of the company. Additionally, you will ensure the correctness of packaging and promotional materials and keep up-to-date with changes in regulatory legislation and guidelines.

Responsibilities:
  • Maintain and follow up on global Marketing Authorizations on the European Market.
  • Manage a product's lifecycle from application submission to national package level in collaboration with different contact persons.
  • Procedural contact person to authorities.
  • Preparation of the administrative sections (Module 1).
  • Compilation of dossiers using document and submission management tool.
  • Communicate outside the organization on behalf of the company with National Competent Authorities and company customers; ensure that relevant information is shared internally.
  • Ensure correctness and grant 'approval' of packaging and promotional materials.
  • Keep up-to-date with changes in regulatory legislation and guidelines.

Requirements:
  • Some years of experience in Regulatory Affairs within the pharmaceutical industry, and experience with document and submission management will be a plus.
  • Fluently in written and spoken English and one of the Nordic languages.