Director of Regulatory Affairs

Black Swans Exist
Director of Regulatory Affairs
Copenhagen, Denmark
Are you ready to take on a pivotal role in shaping the future of women’s health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women’s reproductive health, is seeking a visionary Director of Regulatory Affairs to lead their global regulatory strategies.
About the Role
In this high-impact position, you will drive the regulatory framework for developing and approving innovative biologics, combination drug-device products, and companion diagnostics. You’ll collaborate closely with cross-functional teams and regulatory authorities, ensuring strategies align with global standards and pave the way for clinical success.
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.
- 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 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.
- Proven success with EMA and FDA submissions, as well as 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.
Moreover, you’ll lead the charge in developing innovative therapies that could transform the lives of millions. This role offers a unique opportunity to:
- Shape regulatory pathways for cutting-edge treatments.
- Engage directly with regulatory agencies to drive impactful decisions.
- Expand your career as the organization grows, taking on more projects and leadership opportunities.
Be part of the journey to redefine women’s health.
If you’re a dynamic, flexible, and results-oriented leader with a passion for innovation, we’d love to hear from you.

Daniel Olsen
Senior Business Development Consultant
Daniel Olsen is a Senior Business Development Consultant at Black Swans Exist, where he has been instrumental in the success of the company since May 2021. Specializing in recruitment and talent acquisition, Daniel is passionate about identifying extraordinary individuals who elevate business performance.
View Profile