Regulatory Affairs Director

Job Summary

Leading the Global Regulatory Team, the full-time remote Regulatory Affairs Director will develop comprehensive regulatory strategies for product development and global registration, ensuring effective interactions with regulatory agencies while providing guidance to cross-functional product teams.

Key Responsibilities:

• Develop and execute Global Regulatory Strategic Plans, integrating regional strategies and ensuring alignment with product registration goals
• Direct global regulatory agency interactions and communications, leading core regulatory teams to facilitate effective submissions and approvals
• Collaborate with cross-functional teams to ensure compliance and alignment of global objectives, while mentoring team members and integrating regional insights

Required Qualifications:

• Doctorate degree with 4 years of related experience, or Master's degree with 8 years, or Bachelor's degree with 10 years of directly related experience
• At least 4 years of experience in managing teams or leading projects
• Strong understanding of regulatory activities and their impact on product development
• Proven ability to lead teams and communicate scientific information effectively
• Experience in developing regulatory strategies and navigating complex regulatory environments