Director of Regulatory Affairs
1 day ago
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Senior Business Development Consultant at Black Swans ExistDirector of Regulatory Affairs
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, seeks 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, and 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 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 dynamic, flexible, and results-oriented with a passion for innovation, we'd love to hear from you.
Seniority levelDirector
Employment typeFull-time
Job functionResearch and Science
IndustriesBiotechnology Research and Pharmaceutical Manufacturing
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