Principal Regulatory Submissions Specialist in Germany

Principal Regulatory Submissions Specialist - Germany - Flexible work-style - Permanent

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 involve:

Preparing, reviewing, and coordinating local regulatory submissions
Providing guidance of local regulatory strategy advice to various sponsors
Providing project specific local submission strategies using technical expertise in collaboration with internal departments
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
Supporting feasibility activities, as required.
Ensure the local country study files and filing processes
Mentoring other SIA individuals assigned to projects, as appropriate

What we would like to hear about you:

About your educational experience and/ or relative experience or training
About your clinical experience/ submissions experience
About your effective oral and communication English and German Language skills (preferably C1 in German)
About your 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.