Job Reference: J5632960
Updated On: 13/02/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a Head of Labelling to join a leading, patient focused Global Biopharmaceutical company based in the Berkshire area. As the Head of Labelling you will be responsible for the management of a Global Labelling team where you will have the opportunity to use your innovative mind set develop and improve new processes to build a successful and dynamic department.
You will act as the internal Subject Matter Expert on Labelling processes and procedures and will work cross functionally with other departments. This is a fantastic opportunity for an experience Regulatory Labelling professional with experience of people and project management to lead a department in a successful Global Pharmaceutical company that values innovation and collaboration that allows positive patient impact.
Key Duties and ResponsibilitiesYour duties as the Head of Labelling will be varied however the key duties and responsibilities are as follows:
1. You will create, maintain and improve labelling processes where to will develop labelling strategy to align with wider Global Regulatory strategy. You will be the subject matter expert in Labelling Regulations and will represent the labelling department in audits and inspections.
2. Develop a dynamic team where you will create training strategy to ensure the personal and professional development of your team.
3. Leading CCDS activities including the implementation of new CCDS for assigned projects. This also includes the coordination of approving exceptions to the CCDS where appropriate.
4. Providing Global Labelling input and expertise to the Regulatory Affairs Lead and other members of the Regulatory department with a focus on documentation strategy.
5. Assist Marketing and Business development teams with the creation and review of promotional materials and external communications from a Regulatory Labelling standpoint.
Role RequirementsTo be successful in your application to this exciting opportunity as the Head of Labelling we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences discipline or relevant industry experience in addition to extensive Regulatory Labelling experience with the ability to lead strategic development.
2. Proven industry experience in developing and leading a team of Regulatory professionals where you have develop training strategy and personal development plans.
3. Experience of liaising with internal stakeholders and working in a cross functional matrix.
Key Words: Regulatory Affairs | Labelling | Director | Head of | Pharmaceutical | Biopharmaceutical | Core Company Data Sheet | CCDS | SmPC | Summary of Product Characteristics | PIL | Patient Information Leaflet |
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