Key Responsibilities:To have an in-depth scientific and regulatory knowledge of the therapeutic area and regulatory landscape in Europe, Turkey, Israel and Switzerland providing comprehensive regulatory...
My client, an expanding Clinical Research Organisation are currently seeking to recruit a Regulatory Submissions Manager to join their Clinical Operations team. This position plays a key role in the clinical trial management process. The role will be based from my client's offices in Munich.
Responsible for the collation and review of electronic and Paper CTA's, Publishing, Production, dispatch, logging and archiving for regulatory submissions and Notifications. Also to provide Project Management and Regulatory oversight for submissions.
- Efficiently manage and successfully execute all Regulatory aspects of global start-up;
- Perform quality checks on submission documents and site essential documents (CTAs, ECs)
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits.
- Life Sciences degree qualified
- Extensive industry experience clinical Regulatory Affairs ideally with a CRO. Experience may include CRA or project management experience;
- Strong hands on exposure within Clinical Regulatory submissions.
- Strong oral and written communication skills both in English and German.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.