Director, Regulatory Operations, Europe

The Opportunity:

The Director, Regulatory Operations, Europe will provide strategic and operational leadership for European regulatory operations, establishing the operating model, capabilities, and governance required to deliver a growing portfolio of high-quality regulatory submissions. This role is the senior Regulatory Operations partner to the European Regulatory Affairs organization, translating regional regulatory strategy into integrated submission and lifecycle execution across the EU, EEA, UK, and Switzerland.

Working with senior leaders in regulatory strategy, clinical, CMC, nonclinical, quality, and Global Regulatory Operations, the Director will lead portfolio-level submission planning, regulatory information management, publishing operations, and inspection-ready execution. The Director will build, develop, and lead a high-performing regional regulatory operations capability, including internal staff and external partners, while ensuring regional processes, systems, and data standards scale with the business. While primarily focused on Europe, this role operates within Global Regulatory Operations and will influence global standards and support cross-regional priorities as business needs evolve.

Primary Responsibilities:

Lead European Regulatory Operations and partner with European Regulatory Affairs to translate strategy into submission and lifecycle execution.

Own portfolio submission planning, governance, resourcing, and cross-functional delivery for MAAs, scientific advice, pediatric plans, variations, renewals, and other post-approval submissions.

Ensure high-quality, timely, inspection-ready dossiers, eCTD publishing, and submission readiness.

Own Veeva Vault RIM and all EU and regional regulatory submission portals, gateways, and systems, including data governance, submission tracking, data quality, and applicable EU data standards (e.g., SPOR/IDMP).

Build and lead the European Regulatory Operations capability, including staff, vendors, budget, capacity, and continuous improvement.

Align regional processes, systems, and standards with Global Regulatory Operations and represent Europe in global governance forums.

Required Skills, Experience and Education:

Bachelor’s degree in life sciences or a related discipline; advanced degree preferred.

10+ years of progressive regulatory operations, regulatory affairs, or submission-management experience in biotechnology or pharmaceuticals, including European submission leadership.

Deep knowledge of European regulatory submissions, eCTD, lifecycle management, and applicable EU regulatory data standards.

Experience leading Veeva Vault RIM, regulatory publishing, and EU/regional portal operations.

Proven ability to lead cross-functional teams, vendors, portfolio governance, and complex submission delivery.

Exceptional communication, influence, and stakeholder-management skills.

Preferred Skills:

Experience leading MAAs or other major marketing applications.

Oncology or rare disease regulatory experience is an advantage.

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