Global Regulatory Lead for Oncology Programs

Discover International; Lavamünd; Vor Ort; EUR 180.000 - 240.000; Vollzeit

Zusammenfassung

Discover International is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy and execution for oncology development programs and related assets. This role centers on end-to-end regulatory leadership from early development through registration and lifecycle management, including IND/CTA and MAA activities, with strong cross-functional accountability.

The Senior Director will drive Health Authority engagements, provide strategic oversight for major submissions, and

Qualifikationen

• Bachelor's degree required; Master's/PhD preferred in life sciences.
• 12+ years of regulatory affairs experience in biotech/pharma.
• Experience leading regulatory strategy for oncology or non-oncology programs.
• Proven track record supporting major submissions and/or approvals.
• Experience leading Health Authority interactions and strategy preferred.

Aufgaben

• Lead global regulatory leadership for assigned region/assets, owning the global regulatory strategy.
• Define and drive strategy for development, registration, labeling, and lifecycle management.
• Lead cross-functional governance with Clinical, CMC, Nonclinical, Safety, Biometrics, Medical, and Commercial teams.
• Plan and execute Health Authority interactions (Scientific Advice, pre-submission activities).
• Oversee IND/CTA, MAA submissions, responses to information requests, and advisory preparedness.
• Ensure consistency of CTD modules, risk mitigation, and benefit-risk positioning.
• Prioritize regulatory workstreams based on value, timelines, and likelihood of success.
• Anticipate regulatory risks and drive mitigation plans.
• Provide leadership and development for regulatory team members.
• Support process improvements, templates, and scalable best practices.

Kenntnisse

Regulatory leadership

Strategic planning

Cross-functional collaboration

Regulatory strategy

Stakeholder management

Ausbildung

Bachelor's degree

Master's/PhD preferred

Jobbeschreibung

Discover International is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy and execution for oncology development programs and related assets. This role centers on end-to-end regulatory leadership from early development through registration and lifecycle management, including IND/CTA and MAA activities, with strong cross-functional accountability.

The Senior Director will drive Health Authority engagements, provide strategic oversight for major submissions, and