Head of Regulatory Submission Project Management

WHAT - Summary & Purpose Of The Position

The head of Regulatory Submission Project Management provides strategic and operational leadership for a unified Regulatory Project Management (Reg PM) organization overseeing both early-phase (IND and CTR) and late-phase (NDA/MAA/BLA) regulatory submissions globally.

This role is accountable for establishing and leading a single, high-performing Regulatory Project Management group that ensures consistent, high-quality, and on-time delivery of regulatory submissions across the full product lifecycle. He/she partners closely with Global Regulatory Affairs, Clinical Development, Biometry, Portfolio Project Management, Pharmaceutical Development and other cross-functional stakeholders to drive submission excellence, risk mitigation, and continuous process improvement.

The position directly oversees priority/high exposure submissions and acts as a senior advisor to GRA leadership on feasibility, resourcing and delivery assurance.

He/she is responsible for people leadership, capability building, governance, and standardization of regulatory project management practices, acting as the enterprise excellence champion for submission planning and execution.

WHAT - Main Responsibilities & Technical Competencies

Strategic Leadership & Governance

• Establish, own and lead a single Regulatory Project Management function covering early development (INDs, CTRs, amendments, maintenance) and late-stage submissions (NDA, MAA, BLA, major variations and extensions).
• Define and implement a global regulatory submission project management strategy, aligned with Global Regulatory Affairs and RegOps objectives.
• Develop governance models, escalation pathways, and decision-making frameworks to support complex, cross-regional submissions.
• Single point accountable as a senior regulatory project management advisor to Global Regulatory Leadership for end-to-end submission delivery assurance across early/late submissions and major lifecycle fillings, ensuring “right first time” quality and on-time execution.
  
  

Submission Oversight (Early & Late Phase)

• Provide oversight and/or direct leadership for high-priority, complex, or high-risk submissions, including INDs, NDAs, MAAs, BLAs, and major lifecycle filings.
• Ensure robust submission planning, scenario planning, and risk/opportunity management across all development stages.
• Provide direct leadership for priority/high-exposure submissions, ensuring integrated plans (critical path, dependencies, RACI), risk/issue logs, and decision tracking
• Ensure submission content plans are developed in partnership with GRLs and functional leads and are executed according to agreed quality and timing standards.
  
  

Operational Excellence & Delivery

• Ensure consistent execution of submission activities, including:
• Original applications and major variations
• INDs, CTRs and amendments
• Oversee coordination of document authoring, review cycles, publishing readiness, and final submission delivery in collaboration with Publishing Leads.
• Own the governance for submission-related Health Authority interactions, ensuring robust preparation and rapid, high-quality responses to HA questions (planned Q&A process before questions arrive)
• Monitor submission metrics, timelines, and quality indicators; proactively identify and resolve risks that could impact submission success.
• Drive Submission Excellence / continuous improvement through standards, playbooks, metrics and lessons learned, improve cycle time and predictability across the portfolio
  
  

People & Team Leadership

• Build, lead and develop a Regulatory Project Management organization, including hiring, onboarding, performance management, succession and capability building.
• Coach and mentor Regulatory Project Managers across experience levels, fostering a culture of accountability, collaboration, and continuous improvement.
• Allocate resources across early- and late-phase submissions to ensure optimal workload balance and prioritization.
• Act as a role model for project management excellence and collaborative matrix leadership.
  
  

Process, Tools & Continuous Improvement

• Act as the global champion for regulatory project management methodologies, tools, and best practices.
• Standardize and optimize processes for submission planning, tracking, risk management, and reporting.
• Capture and share lessons learned across submissions to drive organizational learning.
  
  

Cross-Functional & External Collaboration

• Foster strong matrix collaboration across Regulatory Affairs, Clinical Development, PharmDev, Safety, Quality, and external partners.
• Influence without authority to align stakeholders around submission priorities, trade-offs, and decisions.
• Represent the Regulatory Project Management function in senior governance forums and, as appropriate, in interactions with Health Authorities.
  
  

HOW - Behavioural Competencies Required

• Manage Complexity (Thinking Dexterity)
  
  

Makes sense of complex, sometimes contradictory inputs across regions/functions; develops scenarios and focuses the organisation on what truly matters for submission success (critical path, trade-offs, priorities).

• Influences (Being Intentional)
  
  

Builds commitment across a global matrix without formal authority; balances multiple stakeholder needs, creates win-win solutions, and secures timely decisions in governance forums.

• Communicates Effectively (Being Intentional)
  
  

Delivers crisp, structured, executive-ready messages; “tells it how it is” respectfully; uses clear storytelling and reporting to drive decisions, alignment, and urgency around milestones.

• Ensures Accountability (Making a Real Impact)
  
  

Promotes single-point accountability and clear ownership; follows through on commitments; creates an environment where accountabilities, timelines, and next steps are explicit and actively managed.

• Excellence in Execution (Making a Real Impact)
  
  

Plans and prioritizes to meet commitments under pressure; sets clear KPIs and standards, anticipates risks, and consistently delivers outcomes—especially on priority, high-visibility submissions.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Significant experience in the pharmaceutical or biotechnology industry.
• Minimum 10–15 years of experience in Regulatory Affairs/Pharmaceutical Project Management, including extensive regulatory submission and project management experience.
• Strong portfolio/program PM capability (critical path, scenario planning, dependency management, risk-based decision support).
• Proven leadership experience managing teams and complex programs in a global, matrixed environment.
• Strong experience leading international IND, CTR, NDA, MAA, and/or BLA submissions.
• Demonstrated experience managing complex products and development programs across multiple regions.
• Proven leadership of complex, cross-regional regulatory submissions across early and late development, including end-to-end submission delivery assurance and HA Q&A readiness
  
  

Education / Certifications (essential)

• Bachelor’s degree in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences)
  
  

Language(s) (essential)

• Fluent English