Director of Global Regulatory Affairs (Paediatrics)
Location: Europe – Will require relocation (Full relocation assistance provided)
Salary: Up to €130,000 per annum, including a €19,000 car allowance, 20% bonus and other benefits
Job Reference: JO-2209-501552
CPL Life Sciences are collaborating with a growing global pharmaceutical company to hire an experienced & scientific Regulatory Director to manage their paediatric portfolio. In this role, you will be responsible for leading drug development activities, specifically for paediatrics products across the whole company portfolio, globally, and building a team. Other responsibilities include.
· Providing strategic guidance on paediatric products globally
· Working on products in early to late stage of product development as well as post-approval phases
· Providing guidance on regulatory applications to optimize approval timelines (Orphan drug applications, PIPs, accelerated approvals)
· Manage and negotiate complex issues with health authorities
· manage multiple ongoing projects, each at various stages of development.
Requirements
· Global market experience – Ideally EU and US
· Experience working with innovative products, ideally Oncology or Virology
· Experience working with paediatric products & taking lead on transferring/adjusting the strategy for paediatrics
· Experience responding to any HA queries and attending meetings with the local affiliates
· Direct line-management experience isn’t essential but likely to be important in a few years as the team expands
If you would like to apply for this position or discuss our other active positions please contact Charlie on 01189 522 797 or [email protected] .