Senior Regulatory Affairs Manager — Global Clinical Trials

Jobgether SRL; Italia; Ibrido; EUR 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

International environment

Professional development

Leadership growth

Flexible compensation

Descrizione del lavoro

Jobgether SRL is seeking a Manager of Regulatory Affairs in Italy to lead submissions across multiple international markets within a dynamic clinical research environment. You will oversee regulatory and ethics committee submissions, ensuring accurate, timely, and compliant execution throughout the study lifecycle.

You will coach junior colleagues, interact with sponsors and project teams, and contribute to proposals, feasibility assessments, and contract discussions in a senior role.

Competenze

• Bachelor's degree in medical, biological, health, or related sciences.
• Two-year college qualification with nursing or life sciences degree plus 8 years CR experience.
• 5–7 years in pharma/CRO with senior regulatory/clinical start-up experience.
• Strong leadership, planning, and cross-cultural collaboration.

Mansioni

• Lead regulatory and ethics committee submissions across EMEA, APAC, and LATAM.
• Ensure submissions are accurate, tracked, and timely.
• Provide regulatory guidance on country-specific and international requirements.
• Review IMPDs, IBs, and study documents for ICH GCP alignment.
• Communicate submission status, timelines, and risks to sponsors and teams.
• Support BD by reviewing budgets, regulatory sections of proposals, and feasibility reports.
• Contribute to broader regulatory projects and mentor junior staff.

Conoscenze

Regulatory leadership

Project coordination

Stakeholder management

ICH GCP expertise

Clinical research

Cross-cultural collaboration

Regulatory submissions

English communication

Formazione

Bachelor's degree in life sciences

Nursing or life sciences degree + 8 years CRO experience

Strumenti

Regulatory submission tracking tools

Regulatory affairs software

Descrizione del lavoro

Jobgether SRL is seeking a Manager of Regulatory Affairs in Italy to lead submissions across multiple international markets within a dynamic clinical research environment. You will oversee regulatory and ethics committee submissions, ensuring accurate, timely, and compliant execution throughout the study lifecycle.

You will coach junior colleagues, interact with sponsors and project teams, and contribute to proposals, feasibility assessments, and contract discussions in a senior role.