Neuroscience EU Regulatory Lead — Associate Director

Takeda; Zürich; Vor Ort; CHF 159.000 - 219.000; Vollzeit

Zusammenfassung

Takeda seeks an Associate Director, EU Regulatory Lead Neuroscience to shape regional regulatory strategies for neuroscience assets across development and lifecycle. You will drive high-quality submissions and lead interactions with Health Authorities, collaborating with global and regional teams to navigate EU requirements.

You will guide project teams with strategic regulatory insight, oversee submissions, and engage with Health Authorities to ensure timely approvals while monitoring evolving

Qualifikationen

• Bachelor's degree in a scientific discipline required; advanced degree highly preferred.
• Minimum 8 years of experience in drug regulatory affairs, preferably in EU.
• Strong knowledge of EU regulatory requirements across all phases of drug development.
• Experience in regulatory submissions such as clinical trial applications and MAAs.
• Experience interacting with Health Authorities and leading regulatory interactions.

Aufgaben

• Define, develop and execute progressive EU regulatory strategies for neuroscience assets.
• Lead regional regulatory submissions with timely approvals.
• Provide strategic regulatory guidance to cross-functional teams.
• Lead Submission Working Groups and represent the EU in global teams.
• Lead or support interactions with Health Authorities and regulatory meetings.
• Assess regulatory trends and translate impact into proactive strategies.
• Provide regulatory expertise across development, registration and lifecycle management.
• Support value and access interactions with HTA bodies if needed.
• Build strong relationships with Regulatory Affairs and external experts.

Kenntnisse

Regulatory strategy

EU regulatory affairs

Submissions management

Health Authority liaison

Cross-functional collaboration

Ausbildung

Bachelor's degree in science

Advanced degree preferred

Jobbeschreibung

Takeda seeks an Associate Director, EU Regulatory Lead Neuroscience to shape regional regulatory strategies for neuroscience assets across development and lifecycle. You will drive high-quality submissions and lead interactions with Health Authorities, collaborating with global and regional teams to navigate EU requirements.

You will guide project teams with strategic regulatory insight, oversee submissions, and engage with Health Authorities to ensure timely approvals while monitoring evolving