Regulatory Affairs Associate Director

  • £90000
  • pharmaceuticals & medical device
  • UK
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Job description

Job description

Associate Director Regulatory Affairs – CRO UK Wide – WFH/Remote Working

We are currently recruiting for an Associate Director for a leading global CRO company who are looking for someone to join their vastly growing team. The role of Associate Director will focus around providing strategic advice and provide EU regulatory advice to their expanding portfolio of clients worldwide.

We have successfully recruited and supported them recently with key hires and they are again looking to add to their senior regulatory team and offer this role as remote working from home.

The Job roles and Responsibilities:

As Associate Director Regulatory Affairs you will have the following job roles and responsibilities:

  • You will lead procedures in EMA which will include PIPs and Orphan Applications
  • Provide EU regulatory advice on strategy
  • You will provide leadership in meetings with national agencies and EMA
  • You will be client facing and a client lead so strong communication skills are paramount.
  • Assist the management team with support to the team and regulatory consultants
  • To provide assistance to the company with regards to regulatory knowledge

The Person:

In order to be suitable for the position of Associate Director - Regulatory Affairs, ideally you will have the following as a minimum:

  • Relevant degree in a life sciences discipline, biology, chemistry etc
  • Experience in European Regulatory Affairs at development stage
  • A background in liaising with regulatory bodies and EMA
  • US FDA experience would be preferable but is not essential
  • Experience in Orphan Applications and PIPs is essential
  • Ability to be pragmatic and to work with internal staff and clients and external consultants

 

 

 

About the company

The Package:

The successful candidate for the role of Associate Director - Regulatory Affairs will be rewarded with the following package:

  • Salary circa £90,000
  • Holiday allowance of 25 days holiday
  • Work from home/remote working
  • Company pension scheme

Overview

  • Job type: permanent
  • Industry: pharmaceuticals & medical device
  • Earnings: £90,000
  • Added to site: 26/01/21
  • Start date: 01/02/21
  • City/Town: UK
  • County: uk
  • Commutable from: WFH/Remote Working

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