Regulatory Affairs Project Manager

Regulatory Affairs/Clinical Affairs London, United Kingdom Braunton, North Devon


Descripción

This is a great opportunity to join a successful and growing global Pharmaceutical organisation and help shape the future of a diverse Regulatory Affairs function.  This medicines-focused Project Manager Regulatory Affairs role within our Global Regulatory Operations Team is intended to support the business in specialist technical projects.

To be successful in this role you will need to be able to demonstrate in-depth CMC knowledge plus a strong technical knowledge of medicinal products, be able to demonstrate knowledge of European Regulatory requirements and be able to apply this in a practical and creative way. Experience of preparing complex variation packages and responses to Health Authority requests is essential, along with proven project management skills and the ability to deal with a number of internal and external stake-holders. The role will involve coaching and mentoring junior members of the team. Knowledge of formulation development, analytical/laboratory experience and/or previous experience of manufacturing site transfers would also be an advantage.

You will provide technical regulatory expertise to multi-disciplinary teams working closely with internal and external manufacturing sites and other internal departments on complex technical projects to ensure delivery to meet the business needs.

At Perrigo we don’t just create jobs we create careers and give you the tools and support to enhance your career development. This is a fantastic role that will give you the chance to develop skills in executing complex regulatory projects.

We can support with relocation for this role.