Global Regulatory Director - Clinical Trials

ThermoFisher Scientific; Porto; Híbrido; EUR 60 000 - 100 000; Tempo integral

Resumo da oferta

Thermo Fisher Scientific is seeking a Senior Staff Regulatory Affairs Specialist to join our Regulatory Affairs team in Porto. You will interpret global regulations and liaise with cross-functional teams to ensure timely product approvals.

You will shape regulatory strategies, maintain lifecycle compliance, and contribute to the improvement of regulatory information systems, supporting patient safety and business growth across global markets.

Qualificações

• Advanced degree with 6+ years in regulatory affairs, or Bachelor's with 8+ years.
• Knowledge of global regulatory requirements and emerging technologies.
• Proven track record in regulatory submissions to global authorities.
• Excellent communication, presentation, and project management skills.
• Experience liaising with regulatory authorities, trade associations, and professional bodies.

Responsabilidades

• Interpret and disseminate global regulations to cross-functional teams.
• Develop and implement regulatory strategies for new products.
• Maintain compliance through product lifecycles and continuous improvement.
• Support regulatory information systems and tools to enable growth.

Conhecimentos

Regulatory strategy

Global regulations

Stakeholder collaboration

RIMS experience

Regulatory communications

Formação académica

Advanced degree

Bachelor's degree

Ferramentas

RIMS software

Descrição da oferta de emprego

Thermo Fisher Scientific is seeking a Senior Staff Regulatory Affairs Specialist to join our Regulatory Affairs team in Porto. You will interpret global regulations and liaise with cross-functional teams to ensure timely product approvals.

You will shape regulatory strategies, maintain lifecycle compliance, and contribute to the improvement of regulatory information systems, supporting patient safety and business growth across global markets.