Associate Director, Global Regulatory Project Management

General Description

The Director, Global Regulatory Project Management (Director, Global RPM) is a senior strategic leader responsible for supporting, influencing, translating, and executing oncology regulatory strategies across the global drug development lifecycle. This role combines deep regulatory expertise with advanced project management and organizational leadership, driving successful NDA/BLA/MAA submissions and ensuring seamless cross‑functional integration across regions.

• Strategic global leadership support, translating and implementing global regulatory strategies for development programs, ensuring alignment with business objectives and long‑term vision across all major regions (US, EU, China, APAC, LATAM, etc.).
• Serve as a principal advisor to the Global Regulatory Lead (GRL) and Regulatory Regional Leads (RRL), providing strategic regulatory oversight and recommendations for global product development, submissions, and lifecycle management.
• Integrate functional regulatory expertise with PM knowledge to solve complex problems and make sound decisions for the organization on a global scale.
• Maintain awareness of global regulatory environments, policy trends, and competitive landscapes, assessing impact and adapting strategies accordingly.
• Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China, and other international requirements.
• Act as the “COO” to the Global Regulatory Lead, translating strategic regulatory vision into actionable project plans, driving operational execution, and ensuring all cross‑functional activities are coordinated and delivered on time.
• Organize and facilitate cross‑functional meetings with global teams to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwide.
• Proactively identify risks, propose solutions, and manage critical issues related to global regulatory submissions and strategy.
• Oversee preparation and submission of documentation to support investigational and marketing registration packages, ensuring timelines and quality standards are met globally.

• Potential evolution into a formal people‑manager role, providing direct or indirect supervision to Regulatory Project Management staff, including mentoring, coaching, and supporting professional development.
• Guide and develop junior team members to support their growth and long‑term success within the organization.
• Oversee cross‑functional project teams and coordinate activities across global stakeholders.
• Serve as a leader and role model within the Regulatory Project Management function, fostering a collaborative and high‑performance culture.

• Proficiency with project management and document management tools, such as Smartsheets, MS Project, and Power BI.
• Advanced skills in the Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
• Ability to quickly learn and adapt to new software platforms and digital collaboration tools.
• Experience with electronic document management systems and regulatory submission platforms is preferred.

• Bachelor’s degree in Science or related discipline; advanced degree preferred.

• Minimum 10+ years of experience in regulatory project management and regulatory submissions, including both small molecules and biologics, with significant global exposure.

• Demonstrated experience in strategic regulatory leadership, with a proven track record of successful submissions and regulatory PM accomplishments in multiple regions.

• Experience leading cross‑functional and cross‑regional teams, influencing senior stakeholders globally.

• Strong business acumen, strategic thinking, and ability to integrate multiple sources of data for sound decision‑making.

• Excellent verbal and written communication skills; able to understand and translate complex regulatory issues clearly to internal and external stakeholders worldwide.

• Skilled in conflict resolution, negotiation, and fostering open communication across cultures.

• PMP or similar certification preferred.

• Pro…