Regulatory Associate - Berlin, Deutschland - Precision Medicine Group
Beschreibung
Precision for Medicine is not your typical CRO.At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.
What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.
As our organisation continues to grow we are hiring a Regulatory Associate to join our team in Germany. This position can be offered fully home based.
As a Regulatory Associate you will be responsible for submitting initial and subsequent Clinical Trial submissions to Competent Authority (CA) and Ethics Committees (ECs) in the assigned country/counties whilst ensuring compliance with local and international clinical trials regulations and guidelines.
Essential functions of the job include but are not limited to:
- 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
- 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.
- Assisting training of CRAs (if applicable) to ensure they have the necessary knowledge for preparation of the clinical documents required for the regulatory submissions.
- May be requested to support Business Development in review of proposals and /or attendance at bid defence meetings.
Qualifications/Experience**:
- Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- Demonstrative experience in a Regulatory/Submissions position from within a CRO/Pharma organisation ideally covering submissions the DACH region (Germany, Switzerland and Austria)
- Working knowledge of regulatory activities including but not limited to regulatory submissions to HAs and ECs.
- Working knowledge and expertise in GCP/ICH guidelines and applicable country regulations
- Fluent in German and English language
- Computer literacy
- Good communication skills
- Good interpersonal skills
- Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industryleading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for n_ovel therapeutics in various indications._
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