Head of Regulatory Submission Project Management

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.

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.

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.

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.