Associate Director - Global Regulatory Project and Submission Management

General Description: The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and executing regulatory strategies across the global drug development lifecycle. This role blends deep regulatory expertise with advanced project management skills, driving successful NDA/BLA/MAA submissions and ensuring cross-functional integration across regions. The AD, Global RPM proactively anticipates regulatory challenges, influences business decisions, and champions process improvements to secure and maintain market access for products worldwide.
 

Essential Functions of the Job:

       Strategic Global Leadership

• Translate, implement, and advise on 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.).

• Act as a key advisor to the GRL/RRL, providing strategic regulatory oversight and recommendations for global product development, submissions, and lifecycle management.

• Integrate functional expertise with business 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 to expedite submission timelines and support resolve key regulatory issues in all relevant markets.

• Mentor and guide junior 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.

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

Supervisory Responsibilities:  

• This role has the potential to evolve into a formal people-manager position. Over time, responsibilities may include:

• Providing direct or indirect supervision to Regulatory Project Management staff, including mentoring, coaching, and supporting professional development.

• Guiding and developing junior team members to support their growth and long-term success within the organization.

• Overseeing cross-functional project teams and coordinating activities across global stakeholders.

• Serving as a leader and role model within the Regulatory Project Management function, fostering a collaborative and high-performance culture.

Computer Skills: 

• 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 8+ 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.

• Proficiency with project management and document management tools (e.g., Smartsheets, MS Project, Power BI, MS Office suite).

• PMP or similar certification preferred.
   

Key Attributes:

• Proactive, not reactive; 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.