Regulatory Affairs Senior Manager - Market Access
United Kingdom - Basingstoke, United Kingdom - Bishops Stortford, United Kingdom - Bristol, United Kingdom - Cambridge, United Kingdom - Cardiff, United Kingdom - Dartford, United Kingdom - East Anglia, United Kingdom - East Grinstead, United Kingdom - HeUpdate time: March 10,2020
Job Description
Brief role summary:
This is a divisional role in MicroBiology Division’s (MBD) 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 MBD’s clinical products through successful pre-market licenses and renewals. 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 Thermo Fisher regional RA shared services.
Responsibilities:
Minimum Qualifications:
Key Skills:
Preferred Qualifications:
This is a divisional role in MicroBiology Division’s (MBD) 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 MBD’s clinical products through successful pre-market licenses and renewals. 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 Thermo Fisher regional RA shared services.
Responsibilities:
- Lead and develop the RA team involved with Market Access to obtain pre-market licenses for new and existing products globally, renewals & license changes
- Provide Leadership to the RA Operations Team to increase regulatory efficiency and speed of pre-market clearance, and related data submission activities through the development of tools, processes, and analyses of regulatory operations
- Establish metrics & KPIs on license-related activities with regular reporting
- Obtain and communicate actionable RA intelligence globally
- Communicate and collaborate with Product RA to implement the required QMS updates relative to international regulatory requirements
- Resource and AOP planning
Minimum Qualifications:
- Bachelors/Masters Degree, diploma or equivalent combination of qualifications in life science, engineering or legal and related fields.
- Proven previous experience with international regulatory affairs within medical device or IVD industry
Key Skills:
- 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.
- Proven experience interacting and influencing Regulatory Authorities
Preferred Qualifications:
- Previous Thermo Fisher experience in Regulatory function
- RAC accreditation
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