Global Regulatory Affairs Manager

Jobgether; Italia; In loco; EUR 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

International clinical research

Professional development

Leadership growth

Collaborative environment

Descrizione del lavoro

Jobgether, on behalf of a partner company, seeks a Manager, Regulatory Affairs based in Italy to lead regulatory submissions across EMEA, APAC, and LATAM within a dynamic clinical research environment.

You will oversee regulatory and ethics submissions, provide strategic guidance, and coordinate multi‑discipline teams while mentoring junior colleagues. This role supports study lifecycle compliance and business development initiatives.

Competenze

• Minimum 5–7 years of regulatory affairs or clinical start-up experience in pharma or CRO.
• Strong knowledge of ICH GCP and country-specific regulatory requirements.
• Excellent written and verbal English communication.
• Ability to lead teams, manage projects, and coordinate with sponsors and stakeholders.
• Experience supporting business development, budgeting, and regulatory sections of proposals.

Mansioni

• Lead regulatory and ethics submissions across multiple markets (EMEA, APAC, LATAM).
• Ensure timely, accurate regulatory documentation and approvals throughout study lifecycle.
• Provide regulatory guidance to project teams and stakeholders.
• Review IMPDs, IBs, and study materials for regulatory alignment.
• Communicate submission status, risks, and timelines to sponsors and teams.
• Support BD activities by reviewing budgets and regulatory sections of proposals.
• Mentor junior regulatory staff and contribute to regulatory strategy.

Conoscenze

Leadership

Strategic thinking

Planning

Regulatory affairs

Cross-cultural collaboration

English communication

Stakeholder management

Prioritization

Formazione

Bachelor's degree in medical/biological/health/science

Alternate qualification with 8+ years CRO/pharma experience

Descrizione del lavoro

Jobgether, on behalf of a partner company, seeks a Manager, Regulatory Affairs based in Italy to lead regulatory submissions across EMEA, APAC, and LATAM within a dynamic clinical research environment.

You will oversee regulatory and ethics submissions, provide strategic guidance, and coordinate multi‑discipline teams while mentoring junior colleagues. This role supports study lifecycle compliance and business development initiatives.