(Sr.) Regulatory Affairs Specialist - ITALY - Remote

Location: Rome, Latium, Italy

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Requisition Number: 2893

Position Title: Specialist, Regulatory Affairs

External Description:

SUMMARY:  Subject matter expert and contact point for activities supporting Regulatory Authority submissions in coordination with Site Activation & Regulatory (SAR) colleagues for awarded projects. Responsible for planning, initiating and tracking documents required for regulatory submissions and communicating status, risks and actions related to project regulatory activities. May act in a support role to local CRA with regulatory activities when a dedicated regulatory resource is not present locally. Reports to the Site Activation and Regulatory Lead.

 

RESPONSIBILITIES:

  • Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis
  • May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
  • Where required provide local QC of submission dossiers prior to dispatch
  • Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions
  • Identify risks and generate mitigation strategies
  • When possible, foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers
  • Maintain country specific patient information sheet and consent form customization text
  • Maintain country specific drug labeling information
  • Maintain Country Intelligence Pages
  • Be familiar with and comply with SOPs, ICH GCP and applicable regulations
  • Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database
  • Advise the SAR project team about appropriate regulatory strategies
  • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements
  • Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department
  • Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives
  • Assist in the training of SAR colleagues as needed to foster quality delivery throughout the SAR department
  • May support feasibility, site identification or essential document packet activities as needed for critical delivery or for professional self-development if desired

 

OTHER SKILLS AND ABILITIES:

  • Strong organizational and management skills
  • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
  • Self-motivated learning about current regulatory processes and intelligence
  • Excellent written and verbal communication skills to clearly and concisely present information
  • Team-oriented work style; seeks and gives guidance to others
  • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Excellent ability to handle multiple tasks in a fast-paced and changing environment
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
  • Aptitude for contemporary digital systems is helpful

 

REQUIREMENTS:

  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
  • Minimum one year of experience in clinical research, preferably in site activation or regulatory-related function
  • Previous experience within the pharmaceutical/CRO industry
  • Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance
  • Multilingualism preferred; fluent in local language; working knowledge of English

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Employment Type: Regular

Community / Marketing Title: (Sr.) Regulatory Affairs Specialist - ITALY - Remote

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Rome, IT

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