Dompe Albania shpk

  • Tirane, ofroj vend pune Regulatory Officer

Tirane
Tipi
  1. me orar te plote
Fusha | Profili i punes
  1. Farmaceutik
Gjuha
  1. anglisht
Eksperienca
me dhe pa eksperience
Dompé is a leading Italian biopharmaceutical company whose main focus is developing innovative treatment solutions for rare, often orphan, diseases. Based in Milan, Dompé has a major industrial and biotechnology research site in L’Aquila and a R&D unit in Naples. As part of its international development strategy, Dompé opened offices in USA, Spain, Germany and France. In 2015, a commercial office was opened in Tirana, where the Group markets its Primary Care product portfolio and where Dompé is looking for a Regulatory Officer – permanent contract. For the details of the position please see below.

Candidates with the indicated requirements can send the resume in English specifying the Ref. “Regulatory Albania” to the following address selezione.farmaceutici@dompe.com till to 15.06.2019

Main responsibilities and tasks for the position

  • Interact with Global Regulatory (HQ) and support in preparation and management of the regulatory applications for the company products worldwide.
  • eCTD quality-check and publishing of relevant Regulatory Applications for Primary and Biotech Drugs
  • Interact with Local regulatory manager and support registration and maintenance of Dompé Primary Drugs, MD and Food Supplements in Albania and Balkans
  • Interact with Local regulatory manager for management of Cosmetics in Albania and Balkans
  • Interact with Local regulatory manager for review and submission to local authorities of promotional materials
  • Operational activities related to RIM database & RAD Albania archive
  • HQ regulatory administrative activities related to contract, translations, applications’ customization.
  • Back up of activities during Milano office closure


Requirements

  • Life Science Degree
  • Fluency in English and Italian – written and spoken
  • Good computer skills, including MS Office (Excel, Power Point)
  • Optional: previous working experience in the role, knowledge of Regulatory European law requirements
  • Good communication skills, proactivity, teamworking, flexible thinking, integrity
  • Based in Albania
  • Availability to travel and work for short period in HQ offices
 


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