2 months ago
Job title: Global Regulatory Affairs Manager - Home Based
A world-leading pharmaceutical business with a broad portfolio of innovative and established medicines in respiratory, HIV, immuno-inflammation and oncology are seeking a Global Regulatory Affairs Manager. In this role, you will be the Regulatory lead for a portfolio of exciting and fast-paced marketed products developing and driving global regulatory strategy in Europe, China, Japan, and Emerging Markets.
- Development of regulatory strategy(s) and their execution for assigned asset(s) consistent with the strategic activities for the marketed product portfolio.
- Ensuring the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
- Lead regulatory interactions and the review processes
- Recent experience developing regulatory strategies for established products requiring clinical development (e.g. early post-marketing setting, paediatrics, ahead of loss of exclusivity)
- Experience of all phases of the drug development process in regulatory affairs, with particular emphasis on maintenance and lifecycle management of marketed products, including for projects with little or no precedence.
- Extensive knowledge of licensing requirements in all major countries in the region and knowledge of other key Agency processes.
Salary and benefits:
Alongside flexible home working, this role offers a competitive salary and wider benefits package.
To apply for this position or hear further details then please contact Matt Thomas via email@example.com