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Director of Compliance
3 weeks ago
Join us at Black Swans Exist as we revolutionize women's health As a Director of Regulatory Affairs, you will have the opportunity to shape the future of our company and contribute to the development of innovative biologics, combination drug-device products, and companion diagnostics.
About the RoleIn this exciting role, you will drive the regulatory framework for clinical development, Phase 2, and beyond. This includes developing and executing global regulatory strategies, overseeing INDs, CTAs, and other regulatory filings, and leading interactions with EMA and FDA.
- 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.
- 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.
- Advanced degree in life sciences, pharmacy, or related fields.
- 10+ years of global Regulatory Affairs experience, particularly in biologics and combination products.
