Regulatory Affairs Specialist

Michael Page International Italia S.r.l. · Milano, Lombardia, Italia · · 50€ - 70€


Descrizione dell'offerta

Azienda

Our client, a leading pharmaceutical company, is looking for a Regulatory Affairs Specialist.

Offerta

Main Responsibilities of the role:

  • Provide Corporate Regulatory input into the development of new products and due diligence initiatives.
  • Obtain and maintain registration of company's new and existing products worldwide.
  • Support local marketing companies (affiliates and distributors) to ensure fast product registration and good product life cycle management.
  • Manage preparation of new regulatory documents, dossiers, and applications to enable products to be launched and maintained in market.
  • Support key processes related to CMC, quality, labelling, artworks, and local regulations.
  • eCTD management.
  • Support the development of the strongest claims/advertising and promotion possible within the regulations, obtaining the required authorization.

Competenze ed esperienza

Qualifications & Skills

  • Relevant previous experience of at least 5 years in Regulatory Affairs, preferably in Corporate roles.
  • Good knowledge of pharmaceutical laws and regulations (Italy, EU countries, extra EU) and fluent management of the life cycle management.
  • Scientific Degree (Pharmacy, Pharmaceutical chemistry, Chemistry, or related disciplines) and a Master in Regulatory Affairs is preferred.
  • Good communication skills.
  • Curiosity, precision, and organization.
  • Ability to work autonomously or in a cross-functional team.
  • Very good English proficiency.

Completa l'offerta

Great opportunity.

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Candidatura e Ritorno (in fondo)