Senior Regulatory Submission Specialist in Germany

Senior Regulatory Submissions Specialist

Our client, a global Clinical Research Organisation in the Pharmaceutical industry, are looking to engage talent with Clinical Trial Submission experience to join their growing team in Germany.

What you can look forward to:

Fully remote (Based anywhere in Germany)
Enriching work culture promoting flexible hours and work-life balance
Structured pathways for progression within the department and towards management.

What your main duties are:

Preparing, reviewing, and coordinating local regulatory submissions
Providing guidance of local regulatory strategy advice to various sponsors
Developing and implementing local submission strategies
Point of contact at country level for Ethical and Regulatory submission-related activities
Coordinating with internal departments for site start up activities in alignment with submission activities
Working with the clinical team to prepare the regulatory compliance review packages
Ensure the local country study files and filing processes

What we would like to hear about you:

Educational experience and/ or relative experience or training (Bachelor's degree)
Relevant clinical experience/ submissions experience
Effective oral and communication English and German Language skills (preferably C1 in German)
Basic knowledge of regional/ country level regulatory guidelines and EC regulations

Disclaimer

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.