Global Regulatory Affairs Manager: CTA Submissions

ThermoFisher Scientific; Roma; Ibrido; EUR 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

Global environment

Growth opportunities

Descrizione del lavoro

Thermo Fisher Scientific in Italy is seeking a Regulatory Affairs Manager to lead global regulatory submissions and top-tier client engagements. You will coordinate strategies for Phase 1–4 trials, ensuring regulatory compliance and timely delivery in a fast-paced, international environment.

You will mentor teams, manage budgets, and work with business development on proposals. Strong English skills and robust regulatory knowledge are essential for success in this senior role.

Competenze

• Bachelor’s degree or advanced degree in life sciences.
• 9+ years of regulatory or clinical trial experience.
• Proven project management and client-facing experience.

Mansioni

• Lead the preparation of global regulatory submissions for CTA and ensure high quality standards that meet local and regional requirements.
• Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity.
• Provide oversight across multiple studies/projects, ensuring alignment of regulatory strategy, quality, and delivery.
• Act as a senior client-facing lead, contributing to broader regulatory planning and supporting proposals, bid defenses, and scope discussions.
• Ensure quality performance for key/managed projects.
• Manage project budgeting/forecasting functions and maintain accountability for financial and scope management.
• Identify and recognize out-of-scope activities and partner with relevant teams to manage contract modifications.
• Collaborate with business development in pricing and securing new business by contributing to proposals, budgets, and client presentations.
• Provide matrix/project leadership and guidance to team members.
• Ensure compliance with relevant organizational and regulatory SOPs and WPDs.
• Participate in launch meetings, review meetings, and project team meetings.

Conoscenze

Regulatory strategy

Client-facing

Budgeting

Project management

English proficiency

Formazione

Bachelor’s degree or advanced degree in life sciences

Strumenti

Microsoft Word

Excel

PowerPoint

Descrizione del lavoro

Thermo Fisher Scientific in Italy is seeking a Regulatory Affairs Manager to lead global regulatory submissions and top-tier client engagements. You will coordinate strategies for Phase 1–4 trials, ensuring regulatory compliance and timely delivery in a fast-paced, international environment.

You will mentor teams, manage budgets, and work with business development on proposals. Strong English skills and robust regulatory knowledge are essential for success in this senior role.