- Experience Level
- Experienced (non-manager)
Regulatory Manager (EAP)
A leading CRO based is looking to expand their EAP team with the addition of a Regulatory Manager. Their clients range from boutique biotech's to global pharmaceutical companies.
As the new Regulatory Manager, you will be expected to support all key regulatory activities in EAP throughout the lifecycle of global EAP programmes by advising on strategic approach as well as preparing and submitting documents to regulatory authorities.
As part of the remit you will also:
- Take ownership of workload of assigned projects and tasks
- Be the key point of contact for clients regarding regulatory activities for multiple EAPs
- Develop and maintain regulatory SOPs
- Manage all regulatory activities regarding set-up, maintenance, and close-out of live EAPS
- Support business development activities
The ideal candidate will have at least three years' experience in Regulatory Affairs or relevant experience in Clinical Operations or Medical Affairs within the pharmaceutical medicine environment. Experience working with EAPs is preferred but not essential; you will receive full training.
As a Regulatory Manager, you will also possess the following characteristics:
- Bachelor's degree in a life sciences subject
- Strong knowledge and understanding of the drug development process
- Good verbal and written communication skills
- Proficiency in Microsoft Office programs
Market leading salary and benefits package.