Pharma HQ Regulatory Affairs Manager

Settore
Regulatory Affairs
Località
Pomezia
Contratto
Full Time, Tempo indeterminato

Azienda:

Angelini Pharma

Data di pubblicazione:

14 novembre 2019

 

Dettagli

For Angelini Pharma we are looking for a Pharma HQ Regulatory Affairs Manager to insert in “Pharma HQ Regulatory Affairs – Food supplements, Cosmetics, Biocides, Medical devices” division located in Santa Palomba – Pomezia, Italy.

Role and Responsabilities

The main responsabilities will be: 

  • Definition and development of regulatory strategies, specifically guaranteeing that local specificities are adequately considered
  • Apply regulatory knowledge in a highly regulated environment to promote the development and access of new products on the market
  • Contribute to business development and to in-licensing activities, providing regulatory support to ‘Due Diligence’ operations
  • Actively participate in Networks, Associations and other organizations to seize and facilitate any business opportunities
  • Guarantee the preparation and submission of new applications / notifications for marketing authorization within the planned timelines
  • Operate as a “focal point” with local regulatory structures to implement shared regulatory strategies and supervise correlated regulatory activities
  • Contribute to product development projects from the feasibility stage, for regulatory aspects
  • Monitor, analyze and manage regulatory change processes by providing in-depth knowledge and interpretation in order to preventing and mitigating potential risk situations and seizing possible business opportunities

Requirements

  • Degree in Scientific Studies (Pharmacy,Chemistry and Pharmaceutical Technologies)
  • Master or Advanced Course in Regulatory Affairs (nice to have)
  • 5 years of experience within Regulatory Affairs function, specifically in the areas of Medical Devices, Cosmetics and Food Supplements
  • Fluent in English (B2)

We offer a full time and permanent contract.