Regulatory Affairs Associate (Clinical Trial Application)

We are currently looking for a Regulatory Affairs Associate to join the Romanian Regulatory Team. This is an ideal role for someone who would excel working in a fast-paced international team. As part of a multi-national project team, you will take the lead to coordinate the compilation, review and submission of regulatory agency applications for international clinical trials in compliance with international regulatory requirements as well as internal and client standard operating procedures (SOP's). You will coordinate and manage flow of information, track project progress, and identify and solve problems in a team-oriented environment. You will be involved in critical reviews of key technical documents (e.g. clinical trial protocols and reports, study drug labels, and other clinical trial related technical documentation) to ensure regulatory compliance for clinical trial applications, consistency with other key documents and ease of review. You will interface with the project team, the sponsor and the regulatory authorities on regulatory and technical matters, as appropriate. Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.

Key Accountabilities: To prepare and coordinate of regulatory deliverables for assigned projects including close cooperation with regulatory authorities. Working under the general direction of the Project Lead, taking responsibility for ensuring that the client work is performed and delivered on time. Preparing, reviewing and compiling regulatory Clinical Trial Approval applications, amendments, and end of trial notifications. Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOP's. Preparation and review of drug labels to ensure compliance with GMP Annex 13. Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary. Qualifications

Ideal candidate will possess: Initial years of experience in Regulatory Affairs and Clinical Research in Pharma or CRO. A degree in Life Sciences. Advanced degree will be an asset. Fluency in English is a must along with the local language. Experience in clinical study start-up. Ability to work with a multinational team, focusing on multiple issues under tight timelines. Good Computer skills.