£450 - £500 per day
SS - 13143_1564072710
5 months ago
Regulatory Affairs Manager
A 12 month contract opportunity has become available in Cambridge for an experienced Regulatory Affairs Manager.
The role provides project management support to the Regulatory Affairs team. The Regulatory Affairs team is responsible for initial marketing applications, responses to regulatory questions, launch activities, variations and renewals. This role performs a crucial role supporting these activities.
* Working closely with cross-functional submissions teams including Regulatory Affairs, CMC Regulatory Affairs, Publishing and In-country Affiliates to ensure that submissions are prepared to agreed timelines
* Leading meetings with the cross-functional submission teams to plan, coordinate, prioritize, and track submissions for the region and/or specific countries.
* Preparing and maintaining submission plans using MS Project.
* Preparing materials to support the team in developing submission strategies and prioritising activities, such as Visio process maps.
* Preparing and maintaining meeting outputs, action logs etc.
* Developing risk strategies and maintaining risk logs.
* Potential to work on special projects, process improvement projects and supporting EU RA teams as necessary
* Demonstrated ability to discuss and negotiate critical and complex strategic issues with colleagues at all levels
* Able to prioritise and manage their own activities and direct others as required
* Able to articulate complex regulatory project management risks and issues with colleagues at all levels
* Must be capable of leading a small team without direct line management responsibility
* Must be comfortable with activities and priorities changing at short notice
Essential Knowledge, Experience & Skills
* Excellent organization skills and ability to work on several projects simultaneously, to tight timelines.
* Excellent verbal and written communication skills.
* Experience of using MS Project, MS Visio and MS Office, ideally to an advanced level.
* Excellent attention to detail
* Minimum of 5 years Project Management experience.
* Stakeholder management experience
Desirable Essential Knowledge, Experience & Skills
* Experience of collaborating using Zoom, Skype for Business, or similar, with colleagues in other countries, particularly where English is not their first language.
* An understanding of pharmaceutical regulatory processes, manufacturing, change control and global distribution systems is an advantage.
* Experience within a regulated industry is preferred.
* Project management qualification such as PRINCE2 is desirable.
* A degree in a scientific field is preferred.
* Risk management experience
If you are interested in the Regulatory Affairs Manager opportunity, please call Sam on 01483 213 304 to discuss.