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Senior Manager, Global Labelling Operations

Employer
Turner Regulatory
Location
Oxfordshire/Flexible, UK
Salary
Competitive
Start date
29 Sep 2021
Closing date
29 Oct 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Senior Manager, Labelling Operations

This outstanding Labelling opportunity could represent the next stage in your career. Lead and Manage Global Labelling Projects!! This is a superb Labelling role: This is working for an exciting and relatively new Biopharma based in a desirable part of the Home Counties West with flexible working arrangements. Joining this company represents a significant opportunity.
  • 'Hands-on' Project Leading; mentor the Labelling team.
  • Support the Associate Director 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.
  • Global Labelling Committee meetings if necessary.
  • Operate a Labelling 'Subject Matter Expert'

Reporting to the Associate Director Global Labelling, 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. Artwork, 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 - Artwork, 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 with 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 julian@turnerregulatory.com, or submit an application by clicking Apply Now.

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Brief Company Description; 

Turner Regulatory Recruitment is headed by Julian Turner, whose knowledge of Regulatory Affairs Recruitment is significant, and connections with talented candidates in this area unsurpassed.

Julian Turner started his regulatory recruitment career in 2005, since when Julian and his team have created an outstanding database of candidates and other contacts who are always happy to take our calls.

Our candidates willingly engage with us because we have taken the time to get to know them and to understand their plans and their career ambitions. Indeed, it is quite likely we placed them in one of their roles over the past 15 years.

We work closely with our clients’ regulatory line/senior management, HR and talent acquisition/internal tecruitment teams. When they have a Regulatory Affairs vacancy, they rest assured knowing we will put forward on average ten or more exceptional candidates.

We are often called in where other recruiters have failed and are able to fill long-standing vacancies quickly and effectively.

We are proud to work with clients such as Roche, Norgine, BioMarin, Vertex, Shire, ReNeuron, Seqirus/CSL and numerous other organisations, successfully placing candidates in permanent and contract roles within Regulatory Affairs.

If you have a Regulatory Affairs vacancy and would like the opportunity to select from a pool of excellent candidates, please contact Julian and the team at Turner Regulatory Recruitment.

 

 

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Company info
Website
Mini-site
Turner Regulatory
Telephone
0203 695 9477
Location
71-75 Shelton Street
Covent Garden
London
WC2H 9JQ
United Kingdom

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