Regulatory Affairs Director for Biologics

1 week ago

Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

Company Overview

Black Swans Exist is a pioneering biotech company dedicated to revolutionizing microbiome-based therapies for women's reproductive health. Our vision is to develop innovative biologics and combination drug-device products that improve women's lives.

The Position

We're seeking an experienced Director of Regulatory Affairs to lead our global regulatory strategies. As a key member of our team, you will drive the regulatory framework for developing and approving our innovative therapies.

Main 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.
  • 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.
  • Build and enhance organizational capabilities in Regulatory Affairs, fostering a culture of operational and strategic excellence.

What You'll Bring

  • Advanced degree in life sciences, pharmacy, or related fields.
  • 10+ years of global Regulatory Affairs experience, particularly in biologics and combination products.
  • Proven success with EMA and FDA submissions, and regulatory strategy development.
  • Experience navigating complex regulatory landscapes, including CTA or IND approvals.
  • A strategic mindset with operational agility, especially in biotech or small pharma environments.
  • Strong leadership, interpersonal, and communication skills, adept at matrix management.

Opportunities

  • Contribute to the development of innovative therapies that transform lives.
  • Grow your career in a rapidly expanding organization.
  • Engage directly with regulatory agencies to drive impactful decisions.

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