Strategic Regulatory Leader
2 days ago
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 PositionIn 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:
- Developing and executing global regulatory strategies for clinical development.
- Managing the preparation, review, and submission of regulatory filings.
- Leading interactions with EMA and FDA, including scientific advice meetings and regulatory submissions.
- Crafting regulatory plans for biologics and combination products, aligning with EU and US requirements.
- Providing strategic guidance on regulatory submissions, study designs, and compliance.
- Bolstering organizational capabilities in Regulatory Affairs, fostering a culture of excellence.
We Seek Someone With:
- Advanced degree in life sciences, pharmacy, or related field.
- 10+ years of experience in global Regulatory Affairs, particularly in biologics and combination products.
- Proven success with EMA and FDA submissions, and regulatory strategy development.
- Expertise in navigating complex regulatory landscapes, including CTA or IND approvals.
- A strategic mindset with operational agility, ideal for biotech or small pharma environments.
- Strong leadership, interpersonal, and communication skills, effective in matrix management.
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