South Europe Regulatory Lead

Role Overview

As a Regulatory Affairs Lead for Southern Europe, the successful candidate will lead regulatory strategy, operations, compliance and risk management activities across the Southern Europe markets, with direct responsibility for all Regulatory Affairs activities in Italy.

Responsibilities

• Establish strategic direction for all regulatory processes in the Cluster countries in alignment with Operating Unit (OU) Regulatory Affairs strategy & objectives and cluster functions strategy & objectives.
• Ensure the regulatory strategy is executed for the registration of the products intended to be placed on the cluster markets.
• Maintain existing licences and ensure advertising and promotional materials comply with local legislation in all Cluster countries.
• Contribute to the local claims’ development and localisation of the Global and/or OU developed claims in collaboration with stakeholders.
• Lead regulatory governance and ensure local regulatory conformance, corporate policies and procedures are adhered to.
• Develop and implement procedures to ensure regulatory processes and information are traceable and aligned with local regulations.
• Implement an effective regulatory internal control framework, including training, to ensure staff compliance.
• Track and report key performance indicators (KPIs) as defined by OU Regulatory Affairs.
• Facilitate strategic development and deployment of regulatory projects through prioritisation and resource allocation.
• Recruit, develop, and manage staff through a strategically aligned programme.
• Accountable for cluster regulatory objectives, including resource allocation and budgeting for regulatory activities.
• Engage in continuous dialogue with key regulators and health authorities to resolve major issues.
• Develop advocacy strategies to shape evolving legislation/requirements.

Qualifications & Experience

• Bachelor’s degree (preferably in Medicine and Surgery, Pharmacy, or Pharmaceutical Chemistry and Technology, CTF).
• 5+ years of industry regulatory affairs experience.
• 5+ years leading matrixed teams across global regions.
• Multilingual: English and Italian.
• PhD or Master’s degree in life sciences or pharmacy (preferred).
• Strong technical knowledge for assessing regulatory compliance of products.
• Ability to interact with regulatory officials and support advocacy initiatives.

Behaviours

• Agile & distributed decision-making.
• Managing individual and team performance.
• Committed to delivering high quality results.
• Implementing and leading change.
• Building resilience and well‑being in teams.
• Continuous learning and knowledge sharing.
• Developing people and talent pipeline.
• Translating strategy into action.
• Building strong relationships & collaboration.
• Budgeting, forecasting, commercial and financial acumen.

Location

Milan, Italy.

EEO Statement

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands. We guide us in creating an inclusive culture where different backgrounds and views are valued and respected. We are an equal opportunity employer.