RIO Execution Hub Manager

Job title: RIO Execution Hub Manager

About the Role The RIO Execution Hub Manager provides regulatory support to International country and/or cluster Regulatory teams. The Hub Managers work across portfolio phases from initial applications, commercial lifecycle through to product withdrawal. They support numerous regulatory activities including M1 dossier components, local document authoring and/or coordination, simple local HA query responses, and coordination of regulatory input for launch planning. This role acts as the initial point of contact for assigned Country/Cluster under responsibility for Country Regulatory Strategist, Hub Submission Manager/Dossier Manager, and other stakeholders involved in the processes described above. It is expected that this role partners closely with the Country Regulatory Strategist and Hub Submission/Dossier Managers to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to: identification of regulatory requirements, authoring, delivery and/or coordination of local, submission-ready documents, and the quality review/approval of the Dossier provided by Hub Submission/Dossier Managers for the in-scope submission categories defined.

What You'll Do

• End-to-end management of multi-regional, regional and national regulatory dossiers for assigned cluster/country/therapeutic area/products, including initial registration applications and lifecycle management through to product withdrawal.
• Provide regulatory support for cross-functional activities including tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning.
• Serve as the initial point of contact for the RIO Execution Hub Team Lead and key stakeholders for processes under responsibility.
• Perform quality review/approval of the Dossier Table of Contents built by Hub Submission/Dossier Managers for in-scope submissions.
• In some regions, act as Hub Submission Manager; in others, partner closely with Hub Submission Manager.
• Support local document authoring and submission prep (M1 documents, variations, MA applications) and translations; engage with Labeling Hubs for Labels/Artwork updates to align with approved text.
• Provide support for local audit readiness activities (audit interviews, Dear Healthcare Professional Communications, responses to medical info requests).
• Collaborate with Country Regulatory Strategists and cross-functional teams on launch plans; participate in Portfolio and Growth application processes; support international commercial knot prioritisation and Op plan cycles.
• Lead regulatory support for countries/clusters with challenging constraints; act as regulatory matter expert across clusters/regions and drive improvements.

What We're Looking For

• Extensive regulatory expertise across international clusters/regions with experience delivering major submissions and lifecycle management.
• Ability to lead regulatory support in constrained environments and to manage complex regulatory activities (major submissions, national portfolios, tenders, audits, launches).
• Strong cross-functional collaboration skills and experience partnering with Country Regulatory Strategists, Hub Submission/Dossier Managers, and senior stakeholders.
• Familiarity with Growth applications, International Commercial knot prioritisation, and GRS lifecycle prioritisation (CMC and labeling changes).
• Comfortable with local document authoring, HA queries, and liaising with SMEs for complex issues.
• Excellent project management, quality, and compliance focus.

Nice to Have

• Experience with Labeling/Hubs interactions; experience with Labeling Updates; experience across multi-regional/regional portfolios.
• Prior leadership in regulatory lifecycle management for a diverse set of products.

Compensation & Benefits

• Salary range and benefits are not disclosed in the posting.