Regulatory Affairs, UK Liaison

Job Description

Pharma Direct are currently recruiting for a contract Regulatory Affairs, UK Liaison  

MAIN PURPOSE:

The first is to be responsible for UK-specific regulatory oversight on marketed and investigational biologic and NCE products. To do this the candidate should be able to advise the development teams on local strategy and procedures. 

The second aspect is to prepare and deliver regulatory operational plans for assigned projects/products within the broader EU region. 

 

 EXPERIENCE:  

  • Minimum of 5 years of Regulatory Affairs experience within biotech/pharma industry 

  • In-depth knowledge of the drug development, CTA, product registration processes and the MHRA. 

  • Proven ability in project leadership and representing the company in formal meetings including presentations to and negotiations.