Global Regulatory Affairs Leader — Clinical Trials

ThermoFisher Scientific; España; A distancia; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Senior Staff Regulatory Affairs Specialist to interpret and disseminate global regulations while collaborating with cross-functional teams to bring innovative products to market.

You will contribute to regulatory strategies, maintain lifecycle compliance, and support improvements to regulatory tools, enabling patient safety and business growth on a global scale.

Formación

• Advanced degree plus 6+ years regulatory affairs experience or bachelor’s plus 8+ years.
• Deep knowledge of global regulatory requirements and emerging technologies.
• Proven track record in regulatory submissions and filings with global authorities.
• Experience managing regulatory information systems (RIMS).
• Strong communication and presentation skills for complex concepts.
• Advanced project management to handle multiple initiatives.
• Collaborative with stakeholders across functions in a global environment.

Responsabilidades

• Develop and implement regulatory strategies for products.
• Interpret global regulations and disseminate guidance to teams.
• Collaborate with cross-functional groups to bring products to market.
• Support post-market surveillance and vigilance activities.
• Maintain and improve regulatory information systems and tools.

Conocimientos

Regulatory strategy

Cross-functional

Regulatory submissions

RIMS experience

Regulatory communications

Project management

Stakeholder engagement

Global regulatory knowledge

Educación

Advanced degree in science/engineering/pharmacy

Bachelor's degree in science/engineering/pharmacy

Herramientas

Regulatory software tools

Descripción del empleo

Thermo Fisher Scientific is seeking a Senior Staff Regulatory Affairs Specialist to interpret and disseminate global regulations while collaborating with cross-functional teams to bring innovative products to market.

You will contribute to regulatory strategies, maintain lifecycle compliance, and support improvements to regulatory tools, enabling patient safety and business growth on a global scale.