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Regulatory Affairs Strategist

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Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

Black Swans Exist is revolutionizing women's health by developing innovative biologics, combination drug-device products, and companion diagnostics. We seek a visionary Director of Regulatory Affairs to lead our global regulatory strategies.

About the Role

This high-impact position drives the regulatory framework for clinical development, Phase 2, and beyond. You will develop and execute global regulatory strategies, oversee INDs, CTAs, and other regulatory filings, and lead 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.
Key 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.
What We're Looking For
  • Advanced degree in life sciences, pharmacy, or related fields.
  • 10+ years of global Regulatory Affairs experience, particularly in biologics and combination products.