Senior Regulatory Affairs Associate - 1 Year Contract
Parexel International Corporation
Warsaw, Mazovia, Poland
We are recruiting for a Senior Regulatory Affairs Associate on a 1 year Contract in Poland. 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 (SOPs). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies. Having knowledge and experience on (EU) Marketing Authorization Application procedures would be advantageous.
Scope of responsibilities:
• To prepare and coordinate of regulatory deliverables for assigned projects in Poland and other countries, including close cooperation with regulatory authorities
• To act as local regulatory contact and regulatory lead for assigned studies
• Preparing, reviewing and compiling regulatory CTA applications, amendments, and end of trial notifications.
• Working under the general direction of the Regulatory & Access Manager/Project Manager, taking responsibility for ensuring that the client work is performed and delivered on time
• Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOPs
• Preparation and review of drug labels to ensure compliance with GMP Annex 13 and national requirements
• May prepare and/ or deliver presentation with the support of senior colleagues Qualifications• Education: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.
• Minimum Work Experience: Several years’ experience in an industry-related environment (CRO or pharma companies)
• Language Skills: Polish native speaker, fluent vocal and written English. German language would be a plus.
• Results Oriented and pro-active
• Interpersonal Communication
• Teamwork & Collaboration
• Solving Business Problems