European Regulatory Affairs Lead – Oncology (MAA)

Revolution Medicines; Basel; In loco; CHF 130.000 - 190.000; Tempo pieno

Descrizione del lavoro

Revolution Medicines seeks an Associate Director, Regulatory Affairs, Europe to provide strategic regulatory leadership for designated oncology programs across Europe, the EU/EEA, UK and Switzerland. You will align regulatory plans with global goals and drive end-to-end MAA filings while engaging with EMA, MHRA and Swissmedic.

You will lead cross‑functional teams, assess regulatory risks, and ensure timely, high‑quality submissions across complex programs in a fast-paced environment.

Competenze

• Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree (PhD, PharmD, MSc) is desirable.
• A minimum of 8 years in the pharmaceutical/biotech industry and at least 7 years in Regulatory Affairs including strategy roles.
• Significant oncology drug development experience and strong EMA/MHRA submission history.
• Hands-on experience with large, complex regulatory documentation and health agency interactions.
• Ability to lead cross-functional teams and communicate regulatory strategies to senior management.

Mansioni

• Lead regulatory strategy for assigned oncology programs in Europe, aligning with global objectives.
• Plan, prepare and coordinate MAA submissions and lifecycle activities across EU/EEA/UK/Switzerland.
• Act as primary regulatory liaison with EMA, MHRA and Swissmedic as applicable.
• Coordinate deadlines, dossiers, and cross‑functional alignment for regulatory filings.
• Identify regulatory risks and communicate impact to leadership; manage vendor relationships.

Conoscenze

Regulatory strategy

EMA/MHRA submissions

Oncology drug development

European regulatory framework

Cross-functional leadership

Regulatory submissions

Stakeholder management

Project management

Communication skills

Formazione

Biological/life sciences degree

Advanced degree desirable (PhD/PharmD/MSc)

Descrizione del lavoro

Revolution Medicines seeks an Associate Director, Regulatory Affairs, Europe to provide strategic regulatory leadership for designated oncology programs across Europe, the EU/EEA, UK and Switzerland. You will align regulatory plans with global goals and drive end-to-end MAA filings while engaging with EMA, MHRA and Swissmedic.

You will lead cross‑functional teams, assess regulatory risks, and ensure timely, high‑quality submissions across complex programs in a fast-paced environment.