Shreeya Patel is recruiting a Global Regulatory Affairs Manager to join a global pharmaceutical company at their site based in Hertfordshire on a permanent basis.
As Global Regulatory Affairs Manager you will be responsible for:
- Regulatory Strategy Development
- Regulatory Submissions (both MAAs and CTAs)
- Lifecycle Management
- Interfacing with Authorities
- Resource Management
- Financial Management
The role may also include Matrix and Team Management as well as People Management (if assigned direct reports).
As Global Regulatory Affairs Manager you will be managing the life-cycle of marketed products and you will be accountable for the overall quality and compliance of regulatory submission documents to appropriate regulatory bodies. You will also be monitoring the regulatory environment and assessing the impact of new or changing regulations on assigned projects.
- BSc/MS or equivalent in relevant field
- Experience in regulatory methods and processes in industry setting required
- CTA, IMPD, PIP and DSUR experience also preferred
- Marketed products experience
- Development experience
How to apply
For more information or to apply for the role please contact Shreeya Patel on 01438 743047 or email firstname.lastname@example.org. Please quote reference CL25986 in all correspondence. Entitlement to work in the EEA is essential.