RBW Consulting are proud to be partnered with an industry leading, mid-sized global CRO that cover multiple therapeutic areas but have particularly strong focuses on Oncology and Rare Diseases. Due to the recent award of new studies this CRO are currently seeking a Freelance Regulatory Submissions Associate based in Germany to come on board within their Submissions function.
The role will initially be for a 6 month contract at 0.6 FTE, with the scope for an extension and potential to take on further studies!
- Provide support to Global/Regional Regulatory Lead for assigned studies and may on occasion be requested to act as Regional Regulatory Lead.
- Preparation of Clinical Trial Application Forms (Country EudraCT form for EEA countries and/or National Application Form).
- Preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorisations/approvals for the conduct of the Clinical Trial.
- Interaction with CA/EC for study purposes and handling responses to the CA/EC. Providing CA/EC related information as applicable.
- Providing regular updates about CA and EC submissions to Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
- Provide support for other Regulatory submission documents (MAA/NDA, ODD, PIP, Scientific Advice), as requested. Including support for Health Authority Meetings.
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
- Keep an updated knowledge of the local clinical trial laws, regulations and guidelines to perform the assigned regulatory responsibilities.
- Participating in regulatory activities within the company and ensuring regulatory (CA and EC) related activities are performed according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
- Assisting training of CRAs (if applicable) to ensure they have the necessary knowledge for preparation of the clinical documents required for the regulatory submissions.
- Assuming other regulatory responsibilities if required and upon the request of line manager/ Regulatory Leadership.
- May be requested to support Business Development in review of proposals and /or attendance at bid defence.
- 2+ years of Regulatory Submissions experience (EC/CA)
- Fluent in both German and English
- Up to date ICH-GCP knowledge
- Knowledge of current German and European regulations
Please apply here and Harry Henson will be in touch to discuss your application further!
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