Location: Home-based in the UK
Salary: Up to £70,000 per annum dependant on experience
Job Reference: JO-2105-469492
Working within a CRO but directly outsourced to the pharmaceutical business, this role is a good opportunity for someone who has experience supporting centralized submission to the EMA. In this role, you will be responsible for assisting in the planning and preparation of post-approval submissions to the EMA under the direction of the EU Product Regulatory Lead(s).
- Planning, coordination, and preparation of regulatory submissions for products post-MAA approval.
- Coordinating all aspects of regulatory submissions on assigned projects
- Identifying and assessing regulatory risks
- Supporting the development and roll-out of initiatives to maintain compliance
- Supporting preparation for Health Authority Meetings
- Minimum of 4 years’ experience within pharmaceutical/biotechnology regulatory affairs
- Experience supporting centralized procedure applications.
- Understanding of regulations, guidelines, and policy statements
- Experience supporting the preparation of regulatory submissions.
- Well organised, detail oriented, effective written and oral communication skills
Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.