Senior Director Regulatory Affairs

Discover International; Zürich; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Discover International in Switzerland seeks a Senior Regulatory Leader to drive EU regulatory strategy and execution across oncology and non-oncology programs, serving as EU/Global Regulatory Lead from early development through approval and lifecycle management. You will lead EMA/CHMP engagements, manage CTA and MAA submissions, and align with Clinical, CMC, Safety, Medical, and Commercial teams.

The ideal candidate has 12+ years RA experience, strong EU/EMA expertise, oncology preferred, and HA

Qualifikationen

• 12+ years pharma/biotech Regulatory Affairs experience.
• Strong EU/EMA regulatory strategy experience across development phases.
• Proven experience with major submissions and/or approvals.
• Oncology experience strongly preferred.
• Experience leading EMA Scientific Advice and/or CHMP interactions.
• Strong knowledge of EU/ICH regulations and drug development strategy.
• Excellent stakeholder management, regulatory writing and health authority negotiation skills.
• Life sciences degree; advanced degree preferred.

Aufgaben

• Lead EU regulatory strategy and EMA/CHMP engagement, including Scientific Advice.
• Oversee CTA and MAA submissions, regulatory responses and approval activities.
• Partner with Clinical, CMC, Safety, Medical and Commercial teams to align regulatory strategy.
• Identify and mitigate regulatory risks across clinical development, endpoints, CMC, safety and biomarkers.
• Provide regulatory intelligence and strategic advice to senior leadership.
• Lead cross-functional regulatory teams and support development of regulatory colleagues.

Kenntnisse

Regulatory strategy

EMA/CHMP engagement

Regulatory submissions

Oncology experience

EMA Scientific Advice

EU/ICH regulations

Stakeholder management

Regulatory writing

Health authority negotiations

Ausbildung

Life sciences degree

Advanced degree preferred

Jobbeschreibung

A Senior regulatory leader responsible for EU regulatory strategy and execution across oncology and non-oncology development programmes, acting as the EU/Global Regulatory Lead from early development through approval and lifecycle management.

Key Responsibilities

• Lead EU regulatory strategy and EMA/CHMP engagement, including Scientific Advice.
• Oversee CTA and MAA submissions, regulatory responses and approval activities.
• Partner with Clinical, CMC, Safety, Medical and Commercial teams to align regulatory strategy.
• Identify and mitigate regulatory risks across clinical development, endpoints, CMC, safety and biomarkers.
• Provide regulatory intelligence and strategic advice to senior leadership.
• Lead cross-functional regulatory teams and support development of regulatory colleagues.

Requirements

• 12+ years' pharma/biotech Regulatory Affairs experience.
• Strong EU/EMA regulatory strategy experience across development phases.
• Proven experience with major submissions and/or approvals.
• Oncology experience strongly preferred.
• Experience leading EMA Scientific Advice and/or CHMP interactions.
• Strong knowledge of EU/ICH regulations and drug development strategy.
• Excellent stakeholder management, regulatory writing and health authority negotiation skills.
• Life sciences degree required; advanced degree preferred.