Head of Labelling – Regulatory Affairs, Europe
This outstanding Labelling opportunity could represent the next stage in your career. Manage the Team and Lead European Labelling Projects!! This is a superb Labelling role – you will operate as European Lead: This is working for an exciting and well-established Pharma in a desirable and part of Hertfordshire. Joining this company represents a significant opportunity.
- Manage and Lead the European Labelling team; ‘Hands-on’ and Project Leading.
- Support the Head of Global Labelling – provide expert European Labelling advice and input within a Global context
- Lead, guide, and mentor Labelling teams in multiple locations; set objectives, manage and monitor progression.
- Ensure Product Information texts for procedures and review team members text activity
- Represent Labelling within multi-functional teams, and lead internal and external inspections and audits
- Chair and convene Global Labelling Committee meetings
- Operate a Labelling ‘Subject Matter Expert’
This individual is required to be a good problem-solver and possess excellent influencing and negotiation skills. In addition, the candidate will be required to represent the Global Labelling Team at product-specific meetings, Labelling working groups and Labelling governance committee meetings. Operate as subject matter expert providing strategic Labelling advice for European regional Labelling. Good working knowledge of Variations, PIL’s and SmPC’s. Solid experience in Packaging & Artwork.
You will possess comprehensive understanding of strategic Labelling activity and thrive in a fast-paced environment. Project Management and Leading skills are vital, along with a background of working knowledge and experience within Regulatory Labelling Strategy, Tactics & Implementation, throughout the pipeline. You will be experienced in operating with cross-functional teams. Geographical remit: European within a Global context.
The remit is across the pipeline incorporating Registrations and Post marketing – the candidate will need a reasonable understanding of general Regulatory Affairs and will collaborate regularly with European and International Regulatory Teams.
The candidate will have expertise in Regulatory Strategy, Tactics and Implementation within a Labelling context, particularly in European territories.
The company operates more on a matrix-management model hence the candidate must be prepared to be ‘hands-on’ and be heavily involved in the day-to-day management of Labelling Projects. The candidate will need to have a substantial background in general Labelling issues – Prescribing Information, CCDS etc.
A demonstrable working relationship with the major Regulatory Agencies and contacts within the EMA and other national Authorities would be an advantage in terms of company representation.
The successful candidate will possess a solid Regulatory Labelling background within Pharmaceutical of at least 10+ years.
This position is based Hertfordshire, and may require some travel, as necessary.
A generous salary package is on offer for the right candidate, this will include a superb basic, excellent bonus and numerous other benefits.
If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on +44 203 695 9477/+44 1582 290 636; +44 7447 977 330, or email@example.com, or submit an application by clicking Apply Now.