CMC Regulatory Director, FSP Delivery & Strategy

ThermoFisher Scientific; Italia; Remoto; EUR 150.000 - 190.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific seeks a Director of Regulatory Affairs — CMC FSP to provide senior leadership for CMC regulatory services across FSP teams and clients. This role blends CMC expertise with functional oversight, resource planning, business development support, and delivery leadership.

The Director serves as a senior regulatory advisor for client requests and internal queries, offering timely guidance and escalating when needed; overseeing strategy, budgeting, and cross-function

Competenze

• Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
• 12+ years of experience in CMC regulatory affairs and related leadership roles.
• 5+ years of management responsibility.
• Strong leadership skills.

Mansioni

• Provide CMC regulatory subject-matter expertise to clients and internal teams.
• Lead, coach, and develop staff; manage performance and salaries; approve time-related actions.
• Advise on regulatory strategy across development, registration, and lifecycle management.
• Collaborate with business development to price and secure new CMC/FSP work.
• Ensure compliance with SOPs and quality standards across projects.

Conoscenze

CMC regulatory

Leadership

Budgeting & forecasting

Regulatory strategy

Client liaison

Formazione

Bachelor’s degree or equivalent

Strumenti

Microsoft Word

Microsoft Excel

Adobe Acrobat

Descrizione del lavoro

Thermo Fisher Scientific seeks a Director of Regulatory Affairs — CMC FSP to provide senior leadership for CMC regulatory services across FSP teams and clients. This role blends CMC expertise with functional oversight, resource planning, business development support, and delivery leadership.

The Director serves as a senior regulatory advisor for client requests and internal queries, offering timely guidance and escalating when needed; overseeing strategy, budgeting, and cross-function