Remote SVP Regulatory Affairs: Global Strategy & Compliance

Ladders; United States; Remote; USD 350,000 - 390,000; Full time

Benefits offered by this job

Medical, dental, vision

PTO

401K

Performance incentives

Job summary

Ladders is seeking a Senior Vice President, Regulatory Affairs to shape global regulatory strategy across development and commercialization. The role partners with Clinical Development, guides health authority interactions, and ensures successful submissions and post-marketing compliance.

The candidate will build agency relations, align cross-functional stakeholders, and advance an ex-US regulatory roadmap for global access. Remote work is offered with international scope.

Qualifications

• 15+ years in Regulatory Affairs in biopharma or pharma.
• Leadership in regulatory strategy and team management.
• Proven NDA submissions and health authority interactions.
• Experience with small molecules and cardiometabolic diseases is a plus.
• Strong knowledge of ICH, FDA and EMA regulations.

Responsibilities

• Drive global regulatory strategy across development and commercialization.
• Oversee health authority interactions and product labeling.
• Manage global post-approval submissions and compliance.
• Develop ex-US regulatory roadmap leveraging reliance and joint reviews.
• Foster cross-functional alignment for commercialization activities.
• Ensure timely submissions and post-marketing obligations.

Skills

Regulatory Leadership

NDA Submissions

FDA/EMA Knowledge

ICH Guidelines

Health Authority Liaison

Team Mentoring

Global Regulation

Education

Advanced degree in pharm/medicine (PharmD/PhD/MD) preferred

Job description

Ladders is seeking a Senior Vice President, Regulatory Affairs to shape global regulatory strategy across development and commercialization. The role partners with Clinical Development, guides health authority interactions, and ensures successful submissions and post-marketing compliance.

The candidate will build agency relations, align cross-functional stakeholders, and advance an ex-US regulatory roadmap for global access. Remote work is offered with international scope.