• Degree in Life Sciences or related field (PhD preferred; MS/BS acceptable with additional experience).
• 6+ years experience with PhD OR 8+ years with MS/BS in Regulatory Affairs.
• Proven experience in clinical and nonclinical regulatory strategy .
• Hands-on experience with IND/CTA preparation , global clinical trial applications, and FDA Health Authority interactions .
• Experience contributing to Marketing Applications (NDA/BLA/MAA) for clinical and nonclinical modules.

Key Responsibilities

• Lead development and execution of global clinical and nonclinical regulatory strategy aligned with development plans.
• Provide regulatory guidance to cross-functional teams and ensure incorporation of global Health Authority feedback.
• Lead preparation for Health Authority meetings , including FDA interactions, briefing packages, Q&A strategies, and presentations.
• Oversee creation and review of regulatory content for INDs, CTAs, and global clinical trial applications ; maintain submissions through study completion.
• Lead clinical and nonclinical content development for global marketing applications (CTD/NDA/BLA/MAA) and support lifecycle management.
• Provide strategic input on clinical and nonclinical study design and integration of scientific results.
• Coordinate with CROs/vendors for regulatory deliverables and submission activities.
• Support pediatric strategy planning (e.g., PIP) and ensure alignment across regions.
• Review abstracts, manuscripts, publications, and externally released scientific content as needed.