Director of Global Labelling; Strategy / Biopharma / London
- Experience Level
Director of Global Labelling – Strategy!!
You will operate as a Subject Matter Expert in Global Labelling.
This outstanding Senior Labelling opportunity could represent the next stage in your career. Manage the Team, establish and implement Labelling Strategy and Lead Global Labelling Projects!! This is a superb Labelling role – you will operate as Global Strategy Lead: This is working for an exciting Biopharma with ‘cutting-edge’ Biologic and ADTHER Products. Joining this company represents a significant commercial opportunity.
Manage and Lead the Global Labelling team; Strategy, ‘Hands-on’ and Project Leading
Manages commercial Product Labelling End to End; development of Target Product Labels; CCDS, Patient Labelling, Local Labelling/Prescribing Information
Provide expert Global Labelling advice and input
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 possesses 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 Global Labelling.
Good working knowledge of Life-cycle management: Type Ia, Ib and II Variations, Renewals; PIL’s and SmPC’s. Solid experience in Packaging & Artwork.
You will possess a 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: Global.
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 the International Regulatory Teams.
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 Biopharma or Pharmaceutical of at least 10+ years.
This position is based Central London (flexible working), 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 firstname.lastname@example.org, or submit an application by clicking Apply Now.