Strategic Regulatory Leader

2 days ago


Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

Join Black Swans Exist, a pioneer in microbiome-based therapies for women's reproductive health, as a Director of Regulatory Affairs. This pivotal role demands a visionary leader who can drive global regulatory strategies and navigate complex regulatory landscapes.

About the Position

In this high-stakes position, you will oversee the development and approval of innovative biologics and combination products. Your expertise will ensure seamless collaboration with cross-functional teams and regulatory authorities, guaranteeing clinical success.

Key Accountabilities:

  1. Developing and executing global regulatory strategies for clinical development.
  2. Managing the preparation, review, and submission of regulatory filings.
  3. Leading interactions with EMA and FDA, including scientific advice meetings and regulatory submissions.
  4. Crafting regulatory plans for biologics and combination products, aligning with EU and US requirements.
  5. Providing strategic guidance on regulatory submissions, study designs, and compliance.
  6. Bolstering organizational capabilities in Regulatory Affairs, fostering a culture of excellence.

We Seek Someone With:

  1. Advanced degree in life sciences, pharmacy, or related field.
  2. 10+ years of experience in global Regulatory Affairs, particularly in biologics and combination products.
  3. Proven success with EMA and FDA submissions, and regulatory strategy development.
  4. Expertise in navigating complex regulatory landscapes, including CTA or IND approvals.
  5. A strategic mindset with operational agility, ideal for biotech or small pharma environments.
  6. Strong leadership, interpersonal, and communication skills, effective in matrix management.
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