Job title: Senior Regulatory Affairs Project Manager - EU Oncology

A global pharmaceutical company in Berkshire are seeking a Senior Regulatory Affairs Project Manager to work within their European markets. The role will be focused on EU Drug development via Centralised Procedures. You'll have the opportunity to pick up experience within PIPS and Orphans Drug Designations. Multiple launches are planned for 2022 and 2023 so this is a fantastic time to join!

Responsibilities:

• Development of Regulatory strategies in collaboration within other affiliates and cross functional teams
• Understand the European regulatory framework, including regional trends, for initial MAA and follow-on submissions for small and large molecules across the region
• Develop and implement strategy, risk assessment and deliverables for products at all stages if the life cycle within Oncology/Haematology

Requirements:

• Previous experience within Oncology/Haematology is preferential
• Experience of working across a European regulatory environment
• Demonstratable leadership and mentoring experience
• Ability to work cross functionally and with other affiliates
• Extensive experience within Pharmaceutical Regulatory Affairs

Salary and benefits:

A highly competitive salary and extensive benefits package is on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk