Global Regulatory Lead, Oncology Strategy & Submissions

Discover International; España; Presencial; EUR 140.000 - 190.000; Jornada completa

Descripción de la vacante

Discover International in Spain seeks a Senior Director, Regulatory Affairs to lead global regulatory strategy for oncology programs and oversee end-to-end submissions from development through lifecycle management.

You will drive Health Authority engagements, coordinate cross-functional teams across Clinical, CMC, Safety and Commercial, and ensure timely submissions (IND/CTA, MAA) with robust risk mitigation.

Formación

• Bachelor's degree in life sciences or related field.
• 12+ years of regulatory affairs experience in biotech/pharma.
• Proven track record leading regulatory strategy for oncology or other programs.

Responsabilidades

• Lead global regulatory strategy and Health Authority engagement for assigned assets.
• Oversee end-to-end submissions (IND/CTA, MAA) and responses to information requests.
• Coordinate cross-functional governance with Clinical, CMC, Nonclinical, Safety, Biometrics, Medical and Commercial teams.
• Develop and implement risk mitigation plans and lifecycle management strategies.

Conocimientos

Regulatory strategy

Global regulatory lead

Experience with oncology

Stakeholder management

Regulatory submissions

Educación

Bachelor's degree

Master's/PhD preferred

Descripción del empleo

Discover International in Spain seeks a Senior Director, Regulatory Affairs to lead global regulatory strategy for oncology programs and oversee end-to-end submissions from development through lifecycle management.

You will drive Health Authority engagements, coordinate cross-functional teams across Clinical, CMC, Safety and Commercial, and ensure timely submissions (IND/CTA, MAA) with robust risk mitigation.