Regulatory Affairs Specialist

2 giorni fa

Bresso, Lombardia, Italia Zambon A tempo pieno

Zambon
is a multinational pharmaceutical and chemical company that focuses on innovation and development with the aim to improve the quality of people's health and patients' lives. Based on a valuable heritage but strongly focused on the future, its Vision is "Innovating cure and care to make patients' lives better". Zambon operates in the pharmaceutical and chemical business and is present in 20 countries with subsidiaries in three different Continents – Europe, America, and Asia – and over 2900 employees, with manufacturing units in Italy, Switzerland, France, China, and Brazil. Zambon products are commercialized in 84 countries. The company is working on the treatment of specialties and rare diseases, such as Parkinson's disease and Cystic Fibrosis, and is well-established in 3 therapeutic areas: respiratory, pain, and women's care.

The Role:

Zambon SpA
is looking for a "
Regulatory Affairs Specialist
" who will support regulatory activities for pharmaceutical products (especially OTC medicines), medical devices, food supplements, and cosmetics, ensuring compliance with national and international regulations.

Main Responsibilities of the role:

  • Support to obtain and maintain registration of Zambon new and existing products worldwide
  • Support local marketing companies (affiliates and distributors) to ensure fast product registration and best product life cycle management
  • Support manufacturing plants in maintaining regulatory compliance and plan future regulatory changes
  • Liaise directly with Health Authorities
  • Interact with other Company functions e.g. for the preparation and update of Core Company Data Sheets

What we are looking for:

  • Academic background: Degree in Life Sciences/Health Related Sciences (CTF/Pharmacy)
  • Professional experience (minimum period – type): 4-5 years of experience in Regulatory Affairs, preferably in Corporate Roles
  • Skills: English (advanced level, written and spoken), knowledge of European and national regulations (EMA, MDR, EFSA), knowledge of eCTD Manager and Veeva Vault RIMS
  • Ability to work in a team and manage multiple projects simultaneously.

Place of Work:
Bresso (MI)

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