Head Of Regulatory Affairs - EAP

South East England Permanent
  • Rapidly Expanding
  • Expanded Access Program Experience is Essential

About Our Client

Rapidly growing pharmaceutical service provider who specialise in Early Access Programs.

Job Description

Head Of Regulatory Affairs - EAP

The Head of Regulatory Affairs will report to the Managing Director EU.

The role will be responsible for understanding, developing and managing the regulatory strategy for Expanded Access (EAP), Compassionate Use (CUP) and Named Patient (NPP) programmes.

  • Responsible for understanding the EAP, CUP and NPP regulatory landscape
  • Reviewing and maintaining regulatory database
  • Lead Regulatory strategy and operational advice to clients
  • Provide regulatory strategies, writing and review of internal and external documentation to support programs
  • Support senior management and business development teams to implement the right regulatory approach
  • The main point of contact for internal and external regulatory expertise

The Successful Applicant

Head Of Regulatory Affairs - EAP

  • Bachelor's degree in a healthcare/science-related subject
  • Minimum 10 years of experience in the biotech or pharmaceutical industry, and a minimum of 7 years experience in a Regulatory capacity
  • Strong experience leading client and health authority interactions
  • Experience writing and reviewing regulatory documents
  • Experience with regulatory strategy
  • High attention to detail and excellent communication skills

What's on Offer

Competitive Basic Salary + Package

Chloe Baverstock
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Phone number
+44 1727 730 144

Job summary

Contract type
Consultant name
Chloe Baverstock
Consultant phone
+44 1727 730 144
Job reference