Job description:

• Initiation, coordination and tracking of variations for the assigned medicinal products from the company portfolio, approved through EU procedures (MRP, DCP) or national procedures
• Coordination of variations or other activitites after the MA was obtained, taking into consdieration the impact on product launch or replenishement orders which might be affected
• Coordination and tracking of renewals for the assigned medicinal products from the company portfolio, approved throuh EU procedures (MRP, DCP) or national procedures
• Ensuring 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
• Checking the responses to all authorities’ requests and ensuring these are communicated within the deadline imposed
• Communication with third parties to speed up the gathering of necessary documentation
• Ensurign 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
• Collaborating with colleagues from the same department or other departments (e.g. Supply Chain, Business Development, etc), and explaining best strategy for all aspects in relation to MA maintenance
• Informing all involved departments on the status and progress of the assigned projects, so that objectives are met, any potential issue is identified and solutions are being found
• Keeping up-to-date the dabatase as well as relevant trackers
• Periodic checking of information in the database
• Keeping up-to-date with current legislation within area of responsibility
• Training of new team members and constantly supporting junior colleagues, as well as leading sub-teams, as assigned

Requirements:

• Chemist/ Biologist/Biochemist/Pharmacist
• At least 5 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