Regulatory Affairs Manager
The Regulatory Affairs Manager is a divisional role in the Microbiology Division's Global Regulatory Affairs function dealing with International regulatory affairs.
The primary purpose of this role is to lead the team in increasing market access of clinical products through successful pre-market licenses.
It would do so by gathering the necessary regulatory intelligence and creating submissions based on product technical data. The key interfaces for this position would be with Global Regulatory Affairs team, Marketing, Sales and regional Regulatory Affairs shared services
- Collaborating with cross-functional teams to obtain pre-market licenses for new and existing products globally, renewals & license changes
- Develop and report KPIs on license-related activities
- Obtain and communicate actionable RA intelligence
- Lead the QMS updates to SOPs relative to international regulatory requirements
- Excellent communication and presentation skills to all levels within the organisation.
- Adeptness in multinational regulatory strategy, risk-benefit analysis, collaboration with internal and external stakeholders, key opinion leaders and regulators.
- Project management skills (Work breakdown structure, basic Gantt charting, communication plan) to manage regulatory projects
- Ability to develop and manage a high-performance team focused on accountability.
- Ability to lead, influence and innovate within a cross-functional environment.
- Previous experience in Regulatory function
- RAC accreditation
- Ideally Bachelors/Master's Degree, diploma or equivalent work experience
- combination of qualifications in life science, engineering or legal and related fields.
- Proven experience Previous experience with international regulatory affairs within medical device or IVD industry
- It would be Nice to have exposure to Microbiology related devices or products
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales