Job description:

• Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through European procedures (MRP, DCP, CP) or national procedures
• Provide support documentation for the new applications in line with the in force European regulations and /or local pharmaceutical laws depending on the submission type and market
• Ensure that all responses to authorities’ requests are correct, complete and timely submitted
• Communicate with third parties to expedite submissions and ensure regulatory compliance
• Ensure that all the additional processes related to national submissions (pre-reviews, DMF, PMF, GMP accreditation etc.) are submitted on time and that their submission/approval process does not delay the application
• Ensure that accurate and complete information is timely provided to other departments/third parties
• Creation and update of the Product Information (PI), irrespective of the source of the request (from authorities, PRAC reports, internal safety signals, etc.)
• Ensuring prompt support and documents related to the PI
• On-time support for responses to letters of deficiency in relation to the PI as per deadlines imposed
• Provide support for samples preparation and dispatch, when necessary
• Inform the relevant functions on the status and progress of assigned projects to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur
• Maintain the current knowledge of applicable legislation within the responsibility area in line with the most up-to-date provisions
• Ensure that the internal regulatory database and trackers are kept up-to-date

Requirements:

• Chemist/ Biologist/Biochemist/Pharmacist
• At least 3 years Regulatory Affairs experience
• EU procedures experience would be an advantage
• English language: advanced level, both speaking and writing; good understanding of Englishmedical terms
• Computer skills: very good knowledge of MS Office tools
• Ability to work effectively without direct supervision and to be able to report succinctly and efficiently
• Attention to details
• Ambitious, responsible person
• Enthusiastic, proactive
• Teamwork spirit, also able to perform alone
• Analytical thinking, problem solving capacity