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Job Details

PW-6741 Senior Manager Global Regulatory Affairs

Company: AXESS
Reference: PW-6741
Closing Date: 07 Nov 16
Type: Permanent
Salary (£): Competitive
Benefits: Comprehensive

Job Summary:

This global Pharma company is looking for an accomplished regulatory professional to focus on a major asset for Alzheimer's Disease which will be moving into Phase III in 2017. The role will be the EU regulatory lead, work closely with the US-based Global Reg Lead and Project Team and also take responsibility for some marketed products within the Neurosciences therapy area.



  • Global Pharma company
  • Hertfordshire based
  • European role



The appointed person will be the EU Lead for the phase III project and will provide EU regulatory support, including leading the preparation of EU Clinical Trial Applications to support the Phase 3 programme.  This will involve working closely with the US-based Global Regulatory Lead and the Project Team.  The appointed person will also need to take responsibility for some marketed products within the Neurosciences therapy area. 

Regulatory Strategy Development

  • Develops and implements regulatory strategy for own functional area and region
  • Leads issue resolution of regulatory risks by identifying, escalating and monitoring issues          

Regulatory Submissions (CTA, Variations, Renewals)

  • Organizes resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes. Provides regulatory support to project teams for allocated projects            

Lifecycle Management

  • Contributes to the planning, execution, and assessment of product life cycle management activities and strategies            

Interfacing with Authorities

  • Contributes to, and implements, strategy for interactions and negotiations with health authorities 
  • Autonomously handle routine communications with regulatory authorities   



  • BS/MS in relevant field
  • Experience of strategic planning of EU clinical development regulatory submissions (CTAs) and ideally familiarity with VHP procedures
  • Familiarity with EU clinical trial regulations and procedures, ideally including VHP procedures
  • Experience in liaising with regulatory authorities (both in writing and verbally) including the EMA
  • Life cycle management for centralised products, including Type 1 and Type 2 licence variations, negotiating labelling with regulatory authorities
  • Must be able to operate in a complex environment and adapt well to changes
  • Preferred: Experience in the Neurosciences therapeutic area
  • Experience leading scientific advice meetings desirable



For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to quoting reference PW-6741



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Apply for this job:  PW-6741 Senior Manager Global Regulatory Affairs

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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