Director, Global Regulatory Project and Submission Management

For our client, we are seeking a Director, Global Regulatory Project and Submission Management to join the team of a leader in the Pharmaceuticals & Biotech space. This role will guide global regulatory project execution and submission planning for development programs across major regions. You will serve as a key strategic partner to the Global Regulatory Lead, translating regulatory vision into actionable plans and helping keep complex global submissions on track. The position requires close collaboration with cross-functional and cross-regional stakeholders to manage priorities, address risks, and drive timely decision-making. Location: Remote Compensation: $176,000 – $236,000 annually Responsibilities Support and implement global regulatory strategies for development programs across major regions Serve as a principal advisor to the Global Regulatory Lead, providing strategic oversight for product development and submissions Lead and manage complex regulatory submissions across multiple regions, ensuring compliance with international requirements Translate strategic vision into actionable project plans and execution timelines Organize and facilitate cross-functional meetings to coordinate submission activities and drive accountability Proactively identify risks and manage critical issues related to global regulatory submissions Champion process optimization and improvement initiatives within the global regulatory project management function Qualifications Bachelor’s degree in Science or a related discipline; advanced degree preferred 10+ years of experience in regulatory project management and submissions, including small molecules and biologics Demonstrated experience in strategic regulatory leadership with a track record of successful global submissions Experience leading cross-functional and cross-regional teams, influencing senior stakeholders Strong business acumen and strategic thinking with the ability to integrate multiple data sources for decision-making Excellent verbal and written communication skills, with the ability to translate complex regulatory issues clearly PMP or a similar certification preferred Benefits Comprehensive benefits package including Medical, Dental, Vision, and Life Insurance 401(k) plan with company contributions Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA) Paid Time Off (PTO) and wellness programs Opportunity to participate in an employee stock purchase plan and receive discretionary equity awards Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.