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Global Regulatory Leader

3 weeks ago

Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

We are seeking an experienced Director of Regulatory Affairs to join our team at Black Swans Exist. As a key member of our organization, you will play a crucial role in shaping the future of women's health.

Job Description

In this challenging and rewarding role, you will be responsible for driving the regulatory framework for clinical development, Phase 2, and beyond. This includes developing and executing global regulatory strategies, overseeing INDs, CTAs, and other regulatory filings, and leading interactions with EMA and FDA.

  • Craft and refine regulatory plans for biologics and combination products, considering EU and US requirements.
  • Provide strategic and tactical guidance on regulatory submissions, study designs, and compliance.
Responsibilities
  • Develop and execute global regulatory strategies for clinical development, Phase 2, and beyond.
  • Oversee the preparation, review, and submission of INDs, CTAs, and other regulatory filings.
  • Lead interactions with EMA and FDA, including scientific advice meetings, Type A/B/C meetings, and more.
Requirements
  • Advanced degree in life sciences, pharmacy, or related fields.
  • 10+ years of global Regulatory Affairs experience, particularly in biologics and combination products.