Senior Director, Global Regulatory Affairs

  • Permanent
  • England
  • Negotiable GBP / Year

Job title: Senior Director, Global Regulatory Affairs

A growing Immunotherapy Biotech are seeking a Senior Director, Global Regulatory Affairs. This is the first Regulatory Affairs hire for the business and will lead to a team build out at Phase III. This role will focus on both FDA and EMA submissions.

The business has recently gone public with very successful IPO which has provided runway through to 2024. They have two ongoing Phase 2 clinical programmes – Hidradenitis Suppurativa and Psoriatic arthritis.

This role can be fully home-based in the UK, Switzerland or Belgium with occasional travel.

Responsibilities:

  • Develop/coordinate/implement regulatory strategy through a global regulatory approach. This includes development programs (in Dermatology/Rheumatology) and all regulatory strategies to obtain in time approvals by regulatory agencies
  • Responsible for driving global health authority interactions with FDA, EMA, and other local health authorities to facilitate approval of all regulatory submissions
  • Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release to external agencies and investigators
  • Responsible for planning and coordination of all Clinical and CMC sections of regulatory submissions necessary to support clinical studies and product registration.

Requirements:

  • Master’s degree in science and/or PhD
  • Minimum of 15 years of experience within regulatory affairs in pharmaceutical industry/Biotech industry, ideally in relevant disease area
  • Direct experience in working globally and dealing with FDA/EMA and national health authorities from development programs to final approvals and ongoing regulatory interactions
  • Experience in a clinical stage biotech would be beneficial

Salary and benefits:

A competitive salary, annual bonus, long term incentive plan and wider benefits package is on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk

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