Job title: Regulatory Affairs Manager (Europe) – Oncology
A Top 10 Pharmaceutical company in Berkshire are seeking a Regulatory Affairs Manager. This is a European-focused role and will work across an extensive Oncology portfolio. This role will be responsible for ensuring effective product maintenance and lifecycle management in addition to supporting clinical trial strategy.
- Responsible for appropriate Europe Region regulatory input to project teams and Global Regulatory Slides via the Global Liaison and Global Regulatory Teams.
- Responsible for ensuring planned drug development activities comply with Europe Region guidelines and in cases where they do not provide a critical analysis of the risks and issues.
- Makes recommendations to Global Regulatory and drug development teams in order to shape the global strategy in line with regional/commercial objectives
- Supports the drug development strategy; defining options for Scientific Advice/ Paediatric Investigation Plan, creating briefing packages and coordinating and leading agency meetings.
- Defines Europe region filing strategy (including CP, MRP, DCP); identifies risks and issues.
- Pharmaceutical industry experience in Regulatory Affairs or R&D
- European regulatory experience
- Experience working effectively across cultures and in complex matrixed environment.
- Excellent organizational skills and solution driven leadership style
Salary and benefits:
A highly competitive salary, annual bonus and wider benefits scheme is on offer
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org