Vice President Regulatory Affairs - Cluster

Description Overview

We are excited to recruit a Vice President, Head of Regulatory Affairs – Cluster. In this role you will lead the Global Cluster Regulatory organisation and provide senior leadership for in-market regulatory strategy, execution, registration delivery, launch readiness, lifecycle transition and ongoing market support.

This role is the senior regulatory partner to Cluster and Commercial Leadership, translating global regulatory intent into clear local execution that supports business performance, market access, supply continuity and compliant growth.

Your role is accountable for cluster regulatory strategies, national registrations, health authority interactions, labelling and promotional compliance, submission quality, approval, timing, launch readiness, post-approval execution and issue escalation.

As VP, you will define the operating model, decision rights, governance and escalation pathways needed to connect Category Regulatory Affairs, Cluster Regulatory Affairs, Lifecycle Management, Regulatory Operations, Quality, Safety, Supply, R&D and Commercial teams into one execution-focused regulatory voice.

Where required, the role may also directly lead one cluster. In that case, as a  VP  you must maintain clear separation between enterprise leadership and cluster execution, with transparent prioritization, delegation and escalation.

Scope of the Role

Cluster Regulatory Strategy, Execution and Business Partnership

• Define and lead cluster regulatory strategy, translating global regulatory intent into executable market plans aligned to category strategy, commercial priorities and enterprise value creation
• Provide VP-level leadership for registration execution, launch delivery, market access, supply continuity, regulatory risk management and prioritisation across clusters
• Act as the senior regulatory partner to Cluster Commercial Leadership, providing clear options, risks, recommendations and decision support for growth, launch and portfolio decisions
• In-Market Regulatory Delivery and Lifecycle Management
• Lead regulatory delivery from global strategy handover through local submission, approval, launch, post-approval execution and ongoing in-market support
• Ensure high-quality, timely and compliant submissions, authority interactions, approvals, labelling, artwork and launch readiness across relevant product classifications
• Ensure effective transition into lifecycle management, including post-approval commitments, variations, renewals, compliance actions and market-specific maintenance requirements

 

Health Authority Engagement, Governance and Risk Management

• Act as the senior regulatory representative with health authorities, regulatory bodies, industry associations and external forums across clusters
• Lead senior-level escalation, negotiation and issue management where regulatory matters may affect approval timing, supply continuity, claims, compliance position or business value
• Establish governance, metrics and prioritisation to ensure visibility of workload, delivery, risks, dependencies and resource capacity
• Ensure regulatory compliance, inspection readiness, audit preparedness and effective mitigation of in-market regulatory risks

 

Cross-Pillar Integration and Operating Model

• Partner with Category RA, Lifecycle Management, Regulatory Operations, Quality, Safety, Supply, R&D and Commercial teams to ensure strategies, dossiers, claims, hand-offs and execution plans are clear and aligned
• Define decision rights, ownership, escalation routes and ways of working that enable a single regulatory voice across markets
• Drive cross-pillar prioritisation, transparency and resolution of execution challenges through established governance forums