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Job Title: REGULATORY AFFAIRS MANAGER
Location: Siena - Italy
Department: Clinical

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;

Requirements:

  • 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.

We offer:

A contract and salary proportional to the experience of the successful candidate.

Job location:

Siena – Italy

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

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