Regulatory Affairs Pharmacist

Israel · Full-time

About The Position

Medison is a global pharma company on a mission to help patients worldwide get faster access to lifesaving, innovative, breakthrough therapies. We operate in 4 continents and over 25 countries and are growing fast. If you want to be part of our mission and help save patients by getting them the latest treatments, join us!

This role is a wonderful opportunity to join the RA department with key leadership responsibilities for all Regulatory Affairs across a nominated cluster of countries.

Responsibilities

  • Assisting MA registration process- communication with partners, preparation and submission of registration dossier for MA application, communication monitoring during the registration process until MA is obtained; variation management- submission, tracking of approval of all variations
  • Assisting in renewal preparation- communication with partners and HA, submission
  •  Preparation of the SmPC and PIL in the local language as needed
  • Local regulatory requirements consultation
  • Key role in liaising with and managing vendors and partners 
  • Plays a key role in ensuring successful product launches following all local regulations and guidelines

Requirements

  • Bachelor's degree in Pharmacy, licensed by the Ministry of Health (strong advantage) or equivalent degree
  • Requires any previous experience in local RA (IL market)
  • Fluency in English is essential
  • Accuracy, Responsibility, highly collaborative and team-spirited 
  • Strong communication skills, verbally and in writing
  • Excellent interpersonal skills and ability to successfully maintain a professional and trusting relationship
  • Works effectively in highly dynamic and changing environments, displays agility and a constant communication behavior curiosity