Global Regulatory Affairs Leader

ThermoFisher Scientific; Brussel Hoofdstad; On-site; EUR 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific in Brussels is seeking a Senior Manager of Regulatory Affairs to guide global regulatory strategies across device, pharmaceutical, biologic, and diagnostic lines. You will lead submissions, interact with authorities, and ensure lifecycle management.

Collaborate with Quality, R&D, Marketing and Compliance to deliver compliant, timely registrations and ongoing regulatory intelligence.

Qualifications

• Advanced degree with 6+ years of regulatory affairs experience.
• Regulatory affairs certifications are beneficial.
• Strong knowledge of global regulations (FDA, EMA, PMDA, NMPA).
• Experience with regulatory submissions (IND, BLA, NDA, 510(k), CE).
• Proven ability to interact with regulatory authorities successfully.
• Experience leading regulatory affairs staff development.

Responsibilities

• Provide strategic regulatory guidance and lead submission preparations.
• Interact with regulatory authorities and manage regulatory intelligence.
• Collaborate with Quality, R&D, Marketing and other stakeholders to ensure compliance.

Skills

Regulatory strategy development

Regulatory submissions

Cross-functional collaboration

Education

Advanced degree in Life Sciences / Chemistry / Engineering

Bachelor's degree

Job description

Thermo Fisher Scientific in Brussels is seeking a Senior Manager of Regulatory Affairs to guide global regulatory strategies across device, pharmaceutical, biologic, and diagnostic lines. You will lead submissions, interact with authorities, and ensure lifecycle management.

Collaborate with Quality, R&D, Marketing and Compliance to deliver compliant, timely registrations and ongoing regulatory intelligence.