Clinical Regulatory Specialist

작업 내용

Main Purpose:

Responsible for management and coordination of the clinical regulatory submission team (EC and CA submissions in EU), ensuring a smooth process from submission through approval, striving to the highest quality standard in a timely and efficient way.

Main Responsibilities:

• Advice & Expertise:

• Being a subject matter expert who provides guidance and support to sponsors and project teams in the preparation, review and submission of regulatory documentation related to clinical submissions.
• Develop and maintain SOPs and process flows for clinical regulatory submissions in accordance with applicable regulations such as but not limited to EU-CTR and MDR.
• Reviewing and implementing the regulations proactively; for example, the new submission process for the EU Clinical Trial Regulation and Medical Device Regulation.
• Expanding & coordinating a network of clinical regulatory experts globally

• Managing clinical regulatory submissions:

• Working together with our team of Clinical Research Professionals (Clinical Director, Project Managers and Clinical Research Associates) to execute all clinical submission aspects of a start-up process, which includes submission to Competent Authorities and Ethical Committees and any other regulatory party as applicable (ex. BfS-Strahlenschutz, finance departments…)
• Keeping oversight of submissions for all studies, executed in different countries, focusing on Medical Devices, Pharmaceuticals and ATMP’s.
• Ensuring timely and complete submission dossiers which comply with applicable regulations while safeguarding tracking and timely filing of documents.
• Strategizing and coordinating

Education & Experience:

• Master’s degree in (para-) medical sciences or equivalent by experience.

• Minimum 3 years of clinical research experience in a pharmaceutical or medical device company, CRO or regulatory body

• Experience with clinical submissions or as a Start-Up Specialist

• Detailed knowledge of European regulations and guidelines related to Clinical Submissions (i.e. but not limited to ICH GCP E6 R2, EU-CTR, MDR, EMA regulations (device and clinical trials), ISO 14155);

• Proficient in Microsoft Office (Outlook, Word, Excel, and Power Point) and affinity to familiarize with new databases

Skills and Competences:

• Demonstrates ability to make timely and well-reasoned decisions;

• Demonstrates ability to effectively and persuasively communicate verbally and in writing;

• Demonstrates ability to identify and adapt to shifting priorities and competing demands;

• Demonstrates sense of responsibility, integrity and confidentiality;

• Demonstrates proactive approaches to problem-solving with strong decision-making capability;

• Great sense of urgency;

• Creative thinker and fast actioner;

• Emotional maturity;

• Ability to be flexible and to adapt and work effectively with a variety of situations or individuals;

• Gives advice, acts as a consultant for complex projects, leads, manages and directs others;

• Very strong interpersonal skills and the ability to build relationships with stakeholders;

• Highly resourceful team-player, with the ability to also be extremely effective independently;

• Sensitive to cultural differences;

• Fluent in English. Proficiency in Dutch, French and German are a plus, other languages an asset.