We are hiring an experienced Regulatory Associate to join our team in Germany, candidates can be based anywhere in Germany.
Due to the high number of applicants, we can only consider those who have experience performing Clinical Trial Application submissions to Competent Authority (CA) and Ethics Committees (ECs). If you have this experience, we look forward to speaking with you.
To assume regulatory responsibilities including initial and subsequent Clinical Trial submissions to Competent Authority (CA) and Ethics Committees (ECs) in the assigned country(ies) and ensure compliance with local and international clinical trials regulations and guidelines.
Essential functions of the job include but are not limited to:
Keep an updated knowledge of the local clinical trial laws, regulations and guidelines to perform the assigned regulatory
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
Interaction with CA/EC for study purposes and handling responses to the CA/EC.
Providing CA/EC related information as
Providing regular updates about CA and EC submissions to Vice President Regulatory/Designee, to the responsible person coordinating the submissions, to Clinical Project Manager and to the responsible Lead
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.
Regular attendance to Regulatory
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 Director, Regulatory/ VP, Regulatory.
Medical/science background and /or relevant experience
Prior clinical research and regulatory submissions experience
Fluent in German and English
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, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for novel therapeutics in various indications.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.