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Director of Regulatory Compliance and Strategy

2 months ago

Surrey, United Kingdom EPM Scientific Full time

About the Role:

The Director, Global Regulatory Affairs will be responsible for developing, implementing and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.

Key Responsibilities:

  • 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, regulatory strategic development plans and risk assessments, and lead Health Authority interactions.
  • Oversee, contribute to, and/or prepare regulatory submissions.
  • Perform and prepare due diligence assessments that may include risk mitigation strategies.
  • Prepare regulatory teams for and lead meetings, including face-to-face, with Health Authorities.
  • Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance.
  • Manage the development of the ongoing global regulatory strategy.

Requirements:

  • Postgraduate degree (MS/PhD/PharmD) in Pharmacy, Biological Sciences, or other related discipline.
  • 15+ years global regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry.

What We Offer:

  • A competitive salary with benefits.
  • 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.