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