Head of Regulatory Affairs

1 week ago

Egham, Surrey, United Kingdom EPM Scientific Full time
Job Description

**About the Role**

The Director of 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.
  • Oversee, contribute to, and/or prepare regulatory submissions, including due diligence assessments that may include risk mitigation strategies.
  • Prepare regulatory teams for and lead meetings with Health Authorities, including face-to-face interactions.
  • Continually build upon and maintain knowledge of the global regulatory landscape, regulations, and guidance.
  • Manage the development of the ongoing global regulatory strategy, including marketing access activities such as pricing, contracts, and product listing.

**Requirements**

  • Postgraduate degree (MS/PhD/PharmD) 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.

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