EU Regulatory Affairs Lead – Oncology

revolutionmedicines; Basel; Vor Ort; CHF 180.000 - 230.000; Vollzeit

Zusammenfassung

Revolution Medicines seeks an Associate Director, Regulatory Affairs, Europe to lead regulatory strategy and end-to-end MAA filings for oncology programs across the EU, EEA, UK and Switzerland. You will align regional plans with global objectives and champion strategic regulatory solutions.

You will interact with EMA/MHRA/Swissmedic, guide cross-functional teams, and ensure compliance while managing external partners to ensure timely submissions and approvals.

Qualifikationen

• Degree in biological or life sciences, pharmacy, medicine, or related fields.
• An advanced degree (PhD, PharmD, MSc) is desirable.
• 7+ years in Regulatory Affairs with oncology experience preferred.

Aufgaben

• Plan and coordinate MAA submissions for Europe, including timelines and deliverables.
• Serve as regulatory liaison with EMA/MHRA/Swissmedic and cross-functional teams.
• Identify regulatory risks and advise on strategies to mitigate timelines and outcomes.
• Ensure compliance with European regulatory, pharmacovigilance and governance requirements.
• Oversee external vendors/CROs to deliver timely, high-quality submissions.

Kenntnisse

Interpersonal skills

Written communication

Presentation skills

Strategic thinking

Ausbildung

Biological or life sciences degree

Advanced degree (PhD/PharmD/MSc) desirable

Jobbeschreibung

Revolution Medicines seeks an Associate Director, Regulatory Affairs, Europe to lead regulatory strategy and end-to-end MAA filings for oncology programs across the EU, EEA, UK and Switzerland. You will align regional plans with global objectives and champion strategic regulatory solutions.

You will interact with EMA/MHRA/Swissmedic, guide cross-functional teams, and ensure compliance while managing external partners to ensure timely submissions and approvals.