Regulatory Submissions Coordinator DACH Region

​Regulatory Submissions Coordinator DACH Region

Munich, Germany

€35,000 - €55,000 DOE + benefits package

 I am working with a global, full-service clinical CRO who deliver Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. They offer local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

They are seeking a Regulatory Submissions Coordinator to support on many projects across the DACH region. This is a valued role within the team and will be mentored and supported as you develop your skills. Working directly with a team of Regulatory Submissions Coordinators, based in the office in Munich, you will gain valuable hands-on experience to enable you to develop a career in clinical research. The role could suit someone with a little regulatory exposure, or a more experienced Submissions Co-Ordinator looking to add more variety to their career.

 Responsibilities

·         Prepare, review, and file initial CTAs to regulatory authorities and Ethics committees in Germany, Austria and Switzerland

·         Prepare and submit responses to queries and amendments to clinical trial applications

·         Ensure submissions comply with applicable regulations and guidance documents

·         Advise team members on changing regulations and compliance requirements

·         Maintain the Clinical Trial Management System and ensure timely filing of documents

·         Collection of essential documents and preparation essential documents packages for drug release.

Qualifications

·         A minimum of a Bachelor's degree in a Life Sciences field

·         Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies including

formulating responses to queries

·         Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site

·         Knowledge of regulatory guidelines in DACH region

·         Excellent organizational and prioritization skills

·         Use to work independently with a proactive approach

·         Knowledge of Microsoft Office

·         Fluency in German and English

·         Great attention to detail and excellent oral and written communication skills.

This is an award-winning global business which can offer ongoing internal growth opportunities worldwide, and where you can enjoy a competitive total compensation and benefits package. The role is office-based in Munich.

Please apply with your CV today to be considered or call Katie Dunbar on +441273 952176 for more information.