Director, Global Regulatory Project and Submission 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. The Director, Global RPM proactively anticipates regulatory challenges, influences decisions, and champions process improvements to secure on-time submissions and maintain market access for products worldwide

Essential Functions of the Job:

Strategic Global Leadership

• Support, translate, and implement 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.

Global Project Management Excellence

• 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.

Cross-Regional Collaboration

• Build partnerships with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC, commercial) across regions to achieve strategic business goals through knowledge sharing and collaboration.

• Liaise and negotiate with cross-functional teams and regulatory authorities to expedite submission timelines and resolve key regulatory issues in all relevant markets.

• Mentor, guide, and develop junior and mid-level staff in project planning, regulatory processes, and professional development, fostering a global mindset.

Continuous Improvement

• Champion process optimization and improvement initiatives within the global regulatory PM function.

• Lead the development and implementation of regulatory processes and policies, fostering a culture of excellence and innovation across regions.

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Supervisory Responsibilities:

• 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.

Other Qualifications Experience:

• 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.

Key Attributes

• Proactive, not reactive; knows the regulatory lifecycle and anticipates challenges and takes initiative to address them.

• Demonstrates integrity, accountability, and strategic leadership.

• Thrives in a global team environment and seeks excellence as the measure of success.

• Able to balance multiple tasks, prioritize effectively, and meet deadlines across time zones and regions.

Travel:

• Occasional international and domestic travel may be required to support global project teams, attend regulatory meetings, or participate in industry conferences.

• Travel requirements will vary based on project needs and organizational priorities.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.