Job description:

• Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through European procedures (MRP, DCP, CP) or national procedures
• Coordinate the evaluation of possible regulatory strategies and provide support for preliminary reviews of new projects
• Provide support documentation for the new applications in line with the in force 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 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
• Coordinate the arrangements for inspections required by the local authorities
• 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
• Perform regular reviews of the information available in the internal regulatory database

Requirements:

• Chemist/ Biologist/Biochemist/Pharmacist
• 3 – 5 years Regulatory Affairs experience
• English language: advanced level, both speaking and writing
• Experience on EU submissions or other regions represent an advantage
• Ability to work effectively without direct supervision and to be able to report succinctly and efficiently
• Computer skills: very good knowledge of MS Office tools
• Attention to details
• Ambitious, responsible person
• Enthusiastic, proactive
• Teamwork spirit, also able to perform alone
• Analytical thinking, problem solving capacity
• Well organized
• Good communication skills