Apply for this role
Are you an experienced regulatory affairs professional looking to take on management duties?
Do you have experience with mutual, decentralised, and centralised procedures?
We are partnered with a leading and expanding pharmaceutical CRO who are looking to add a Regulatory Affairs Manager to their team due to their ever increasing portfolio of clients and work load. This is a fantastic opportunity to join a leading CRO with a strong and supportive team.
The Job roles and Responsibilities:
As Regulatory Affairs Associate Manager you will have the following duties within your role:
- Write and review dossiers for centralised, decentralised procedures
- Preparation of marketing authorisation applications
- To manage junior staff within the regulatory team
- To train and mentor junior members of the team
- Manage projects
- Write and review SOPs and processes
To be suitable for the position of Regulatory Affairs Associate Manager, ideally you will have the following:
- Degree in a relevant scientific subject
- 5 years plus experience with regulatory affairs
- Supervisory or management experience would be advantageous
- Strong understanding of application types and mutual recognition, decentralised and centralised procedures
- International regulatory affairs knowledge would be beneficial
About the company
The successful candidate for the role of Regulatory Affairs Associate Manager, will receive the following:
- Salary between £45,000 - £60,000 DOE
- 25 days holiday plus bank holidays
- Pension scheme
- Remote working but will need t be commutable to their offices in Essex for occasional site meetings