Global Regulatory Strategy Lead for Biopharma

ThermoFisher Scientific; Brussel Hoofdstad; Presencial; EUR 140.000 - 190.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Global Regulatory Lead to drive regulatory strategy across the product life cycle. You will partner with business teams to enable timely filings, product launches, and compliant post‑approval activities, shaping global regulatory affairs across major regions.

In this senior role, you will mentor teams, coordinate INDs, BLAs, and MAAs, manage vendors, monitor regulatory changes, and provide clear guidance to commercialization, medical, legal, quality, and PV

Formación

• Minimum 10 years of regulatory affairs experience in biopharmaceuticals.
• 5–7 years in global leadership roles focusing on FDA, EMA or PMDA.
• PhD or PharmD preferred.
• Strong coordination of regulatory documents for medicine approvals (INDs, BLAs, MAAs).
• Excellent communication and stakeholder management skills.

Responsabilidades

• Provide strategic, operational, and tactical regulatory insight globally.
• Guide filing strategy and coordinate across disciplines for timely filings.
• Oversee regulatory affairs vendors involved in marketing authorization filings.
• Contribute to regulatory filings including INDs, BLAs, and MAAs with the regulatory team.
• Lead post-approval activities including maintenance and program user fees.
• Monitor global regulatory landscape and communicate changes as required.
• Serve as regulatory business partner to local commercialization teams.
• Collaborate with medical, legal, quality, PV and distribution to support business decisions.

Conocimientos

Regulatory leadership

Global regulatory

Project management

Stakeholder communication

Regulatory strategy

Cross-functional collaboration

Educación

PhD or PharmD preferred

Descripción del empleo

Thermo Fisher Scientific is seeking a Global Regulatory Lead to drive regulatory strategy across the product life cycle. You will partner with business teams to enable timely filings, product launches, and compliant post‑approval activities, shaping global regulatory affairs across major regions.

In this senior role, you will mentor teams, coordinate INDs, BLAs, and MAAs, manage vendors, monitor regulatory changes, and provide clear guidance to commercialization, medical, legal, quality, and PV