Senior Manager – EU Regulatory Lifecycle Strategy – Global CRO – Remote (UK only) - £competitive, bonus, benefits
This is an exciting time to join this market leading, global CRO based in the UK. You’ll predominantly be responsible for the planning and preparation of post-approval submissions to the EMA under the direction of the EU Product Regulatory Leads.
A global, well known CRO are now recruiting for Senior Manager – EU Regulatory Lifecycle Strategy to join their already well-established team. You’ll be working directly with one of their major biotech clients on an exciting pipeline of new products. Offering great training and development, this company has a huge interest in developing their employees to a high standard.
- Global CRO
- Working across exciting projects with one major client (global biopharma)
- Excellent career progression opportunities to Senior Manager, Associate Director and beyond
- Great training and development
Working on a number of exciting projects for one major biopharma client, the Senior Manager – EU Regulatory Lifecycle Strategy will be responsible for;
- Leading the planning, coordination and preparation of regulatory submissions, supporting the EU Regulatory Lead for products post MAA approval
- Identify and assess regulatory risks associated with assigned projects
- Provide input to Regulatory lead for Regulatory Senior Management teams
- Support preparation for Health Authority Meetings
- Monitor and analyse appropriate regulatory agency activities in areas of interest to the company and assess impact on assigned programs
- Build and maintain relationships with relevant regulatory agencies
- Responsible for defining strategies for meeting and keeping post approval compliance
To apply for this role as Senior Manager – EU Regulatory Lifecycle Strategy our client is hoping for someone with the following skills and experience
- Ample pharmaceutical/biotechnology industry experience with technical management experience
- Good experience in Regulatory Sciences
- Experience leading EMA centralised submissions
- Experience in interpretation of regulations, guidelines and policy statements
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
What should you do next?
This Senior Manager – EU Regulatory Lifecycle Strategy role is one not to be missed; it encompasses the opportunity to work on a highly successful team on some new and exciting products with one major biopharma client. To discuss this Senior Manager – EU Regulatory Lifecycle Strategy role further or to find out about other Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.
Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.