Our client are a global science led healthcare company who manufacture and commercialise quality medicines to patients. Their global portfolio includes a number of well known brand products as well as global key brands including generics, biosimilars and over the counter products. Due to growth and expansion they are now recruiting within their regulatory teams and currently looking for a Senior Regulatory Officer - Labelling.
- You will be aware of labelling requirements including internal and external legislation, regulations and SOP's also guidance and templates whilst maintaining company core data sheets and local labelling deviations.
- You will review of proposed or approved PI texts for compliance with relevant mandated safety triggers, brand leader and CMC data and you will also be required to the authoring of the SmPC, confirming compliance with mandated safety triggers, brand leader, CMC and labelling requirements.
- Authoring of the Package Leaflet and Labelling ensuring consistency with the proposed or approved SmPC, relevant safety triggers and Labelling requirements.
- You will work with Global Product Safety and Risk Management contacts to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team.
- As the Senior Regulatory Officer you will support the Regulatory Leads with response to questions and requests for further information, which impact PI texts.
- You will support brand leader monitoring process.
- You will have a BSc in a relevant life science or related area.
- Working knowledge of the regulatory pharmaceutical industry including labelling.
- Previous experience of Document Management System
- Excellent time management and prioritization skills.
- IT literate with proficiency in using word, excel and powerpoint.
If this exciting opportunity sound like something you could be interested in please contact me and we can discuss the role and company in greater detail.