Senior Associate, Consultant or Senior Consultant, Regulatory Affairs - German Language Skills

Parexel International Corporation

Poland, Remote

We are recruiting for Regulatory professionals with German Language skills to join our European regulatory team. We can consider Senior Associates, Consultants or Senior Consultants of Regulatory Affairs. We are considering candidates based in Poland or Lithuania.You will be responsible to coordinate, prepare, and submit CTA of assigned studies to the Regulatory Authorities. You will be responsible 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). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.Scope of responsibilities:

• To prepare and coordinate of regulatory deliverables for assigned projects in , Germany 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 And 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 SOP's

Job Qualifications :

Education:Bachelor’s Degree in a Scientific Discipline, Advanced Degree Preferred.Minimum Work Experience:

Minimum of 6-12 months work experience in an industry-related environment (CRO or pharma companies).Skills:

• Fluency to communicate at a business standard verbally and in writing in English, German and local language• Results Orientation• Interpersonal Communication• Teamwork & Collaboration• Problem Solver


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