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Regulatory Affairs Director

2 months ago

surrey, United Kingdom EPM Scientific Full time
About the Role

The Director, Global Regulatory Affairs will be responsible for developing and implementing global regulatory strategies to secure and maintain market access for our products. This role will provide high-level strategic and operational regulatory direction and mentorship on projects, including general regulatory strategies, regulatory requirements for clinical studies and marketing approvals in international markets, and regulatory strategic development plans and risk assessments.

Key Responsibilities

  • Provide strategic and operational regulatory direction and mentorship on projects
  • Oversee, contribute to, and/or prepare regulatory submissions
  • Perform and prepare due diligence assessments, including risk mitigation strategies
  • Prepare regulatory teams for and lead meetings with Health Authorities
  • Continually build upon and maintain knowledge of the global regulatory landscape, regulations, and guidance
  • Manage the development of the ongoing global regulatory strategy
  • Marketing access activities, including pricing, contracts, and product listings

Requirements

  • Postgraduate degree in Pharmacy, Biological Sciences, or other related discipline
  • 15+ years of global regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry
  • Solid knowledge of FDA, EMA, and other global regulations and ICH guidelines
  • Expert in product development and experience in early to late stage as well as post-approval phases
  • Demonstrated experience in leading face-to-face meetings with FDA, EMA, and/or other Health Authorities
  • Preparation of New Drug Applications and Marketing Authorisation Applications in eCTD format
  • Obtain Orphan Drug Designations in Europe and US
  • High level of personal integrity and ethical behavior
  • Strong leadership and staff development skills
  • Strong attention to detail and time management
  • Strong written and communication skills

What's on Offer

  • A competitive salary with benefits
  • The chance to contribute to and be part of a team whose work directly benefits healthcare and strives to improve people's lives
  • A real hands-on opportunity to gain a high degree of commercial exposure
  • The chance to work alongside world-leading scientific experts
  • Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery