Associate Director, Global Labelling / Biopharma / Remote Working

7 days left

21 Apr 2021
21 May 2021
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Associate Director, Global Labelling / Biopharma / Remote Working

This outstanding Labelling opportunity could represent the next stage in your career. Manage the Team and Lead Global Labelling Projects!! This is a superb Labelling role - you will operate as a Global Labelling Lead: This is working for an exciting and relatively new Biopharma based in a desirable part of the Home Counties West. Joining this company represents a significant opportunity.
  • 'Hands-on' Project Leading; mentor the Labelling team.
  • Support the Head of Global Labelling - provide expert European and 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.
  • Chair and convene Global Labelling Committee meetings if necessary.
  • 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 Global Labelling. Excellent working knowledge of All Labelling changes throughout the Lifecycle. Company Core Data Sheets (CCDS); good working knowledge of Type Ia, Ib and II 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: 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 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 would be an advantage in terms of company representation.

The successful candidate will possess a solid Regulatory Labelling background within Pharmaceutical of at least 8+ years.

This position is based Oxfordshire, but remote working is permitted.

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, or submit an application by clicking Apply Now.

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