Senior Director Regulatory Affairs

Discover International; Basel; On-site; CHF 180,000 - 250,000; Full time

Job summary

Discover International seeks a senior regulatory leader to drive 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.

The role requires extensive EU/regulatory affairs experience, with strong EMA interactions and a track record in major submissions. Oncology focus and cross-functional collaboration are essential.

Qualifications

• 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.

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.

Skills

EU/EMA regulatory strategy

Regulatory writing

Health authority negotiation

Stakeholder management

Cross-functional leadership

Regulatory leadership

Education

Life sciences degree

Advanced degree preferred

Job description

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.