Senior Manager, Regulatory Affairs
CK Clinical are recruiting for a Senior Manager, Regulatory Affairs to join a to join a global pharmaceutical company. This will be a permanent role based at their offices in Hertfordshire.
The appointed person will be involved in supporting European regulatory activities for the companies exciting neurology pipeline, which includes two compounds currently in Phase 3 development in early Alzheimer's Disease. Opportunities to contribute to innovative global regulatory strategies will be available as well as opportunities for involvement in US regulatory activities.
The appointed person will also be the EU Regulatory Lead for an early phase compounds targeting rare epilepsies, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3.
Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for the above.
- Regulatory Strategy Development Develops and implements regulatory strategy for own functional area and region Leads issue resolution of regulatory risks by identifying, escalating and monitoring issues.
- Regulatory Submissions (CTA/MAA) Organizes resources and processes across multiple teams/functions to develop and deliver complete regulatory submissions within agreed timeframes. Provides regulatory support to project teams for allocated projects.
- Lifecycle Management Contributes to the planning, execution, and assessment of product life cycle management activities and strategies .
- Interfacing with Authorities Contributes to, and implements, strategy for interactions and negotiations with health authorities.
- Resource Management Enhances the capabilities of current resources (tools, systems, vendors, etc.), technologies, and processes for the team May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines.
- Financial Management Manages team finances in compliance with financial standards and guidelines Assist the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalate issues when appropriate.
- Matrix and Team Management Provides feedback, sets clear tasks and objectives and coaches team members on a periodic basis.
- BSc/MSc in relevant field.
- Experience with EU and/or UK regulatory processes and environment, including clinical trials.
- Regulatory strategy experience and strong strategic thinking skills.
- Experience with liaising and negotiating with regulatory authorities, both verbally and in writing.
- Experience with EU scientific advice, EU Paediatric Regulatory procedures and Orphan drugs.
Apply: For more information or to apply for this position, please contact Amy on 01438 842979 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference number 47631 in all correspondence.