Philogen would like to hire a Regulatory Affairs Manager who will collaborate with other functions in the Clinical Department and will report to the Management.
In particular, the selected candidate will carry out the following tasks:
- Preparation of documents for, e.g., submissions of initial clinical trial applications, amendments, notifications, communications and replies to requests from regulatory agencies;
- Gathering, evaluating, organizing information necessary for regulatory agencies and other third parties;
- Updating relevant clinical documents such as patient information cards and informed consent forms in compliance with the master reference documents;
- Coordination of preparation and shipment of final documents for submission;
- Negotiation with regulatory authorities;
- Ensuring that quality standards are met and submissions meet deadlines;
- Performing the registration, update and posting of results of Philogen studies in mandatory clinical trials and publication databases;
- Good knowledge of procedures related to Marketing Authorisation Applications in EMA and FDA;
- Managing the update of the Trial Master File and archiving of the documentation regarding the Competent Authorities and Ethics Committees of all Philogen studies in collaboration with the CTA;
- Prepare and revise controlled documents including clinical Forms, Templates and Standard Operating Procedure (SOPs) referred to the Regulatory Affairs;
- training clinical staff in regulatory policies or procedures;
- Keeping up-to-date with changes in regulatory legislation and guidelines and evaluating applicable laws and regulations to determine impact on department activities;
- Degree in a Life Sciences discipline.
- Previous experience in a similar role.
- Excellent written and oral communication skills.
- An excellent level of English, both written and spoken.
A contract and salary proportional to the experience of the successful candidate.
Siena – Italy