Posturi disponible

RA Maintenance Specialist

29.8.2018

Job description:

  • Initiate, coordinate and track the variations for the assigned medicinal products from the company portfolio, approved throuh national procedures in APAC or EU or EU procedures;
  • Coordinate the variations or other activitites after the MA was obtained, taking into consdieration the impact on product launch or replenishement orders which might be affected;
  • Coordinate and track the renewals for the assigned medicinal products from the company portfolio, approved through national procedures in APAC or EU or EU procedures;
  • Ensure supporting documentation on variations, renewals, MA transfers, as well as any other activities after the MA was obtained, as per all current legislation/ regulations in place;
  • Check the responses to all authorities’ requests and ensuring these are communicated within the deadline imposed;
  • Communicate with third parties to speed up the gathering of necessary documentation;
  • Ensure that complete and correct documentation is received, so that responses are sent to the authorities’ requests, wihtin the deadline imposed by that specific authority/legislation in place;
  • Keep up-to-date the dabatase as well as relevant trackers.

Requirements:

  • At least 3 years Regulatory Affairs/Quality
  • EU procedures experience is recommended for this position
  • Ability to work effectively without direct supervision and report succinctly and efficiently
  • English language: advanced level, both speaking and writing; good understanding of English medical terms and CMC documentation
  • Computer skills: very good knowledge of MS Office tools
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