Director of Global Compliance

3 days ago


Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

Pursue a career-defining opportunity as a Strategic Regulatory Leader with Black Swans Exist. Our clinical-stage biotech company is pushing the boundaries of microbiome-based therapies for women's reproductive health.

About the Job

As a key member of our team, you will develop and execute global regulatory strategies, driving the approval of innovative biologics and combination products. Your expertise will ensure alignment with global standards and facilitate clinical success.

Responsibilities Include:

  1. Creating and implementing global regulatory strategies for clinical development.
  2. Leading the preparation, review, and submission of regulatory filings.
  3. Collaborating with EMA and FDA on scientific advice meetings and regulatory submissions.
  4. Crafting regulatory plans for biologics and combination products, adhering to EU and US regulations.
  5. Providing strategic guidance on regulatory submissions and study designs.
  6. Bolstering organizational capabilities in Regulatory Affairs, promoting operational excellence.

Requirements:

  1. Degree in life sciences, pharmacy, or related field.
  2. At least 10 years of experience in global Regulatory Affairs, specializing in biologics and combination products.
  3. Success with EMA and FDA submissions and regulatory strategy development.
  4. Expertise in navigating complex regulatory landscapes, including CTA or IND approvals.
  5. Strategic thinking 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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