Senior Manager Core Labelling Strategy

Role Overview

We represent a global pharmaceutical corporation searching for a Senior Manager to lead Core Labelling Strategy. This permanent, full-time appointment is based in North Dublin, with an expected onsite presence of roughly three days per week.

Key Responsibilities

• Oversee the labelling process and development of compliant Core Labelling documentation for company products worldwide, including Global Promotional review and approval.
• Lead generation, preparation, examination, and endorsement of global labelling documents such as Target Product Labels, Core Company-Approved Documents, and Core Patient Information, along with regional labelling documents including EU Summary of Product Characteristics (SmPCs) and US Prescribing Information (USPI).
• Drive labelling strategy in collaboration with Global Regulatory teams, ensuring alignment with the overall regulatory strategy and providing expert advice on labelling regulations, processes, and competitor impact analysis for multiple regulatory submissions.
• Collaborate closely with project leads and regulatory matrix teams to secure strategic, effective, and proactive labelling development, interfacing with senior leadership and subject matter experts on business and labelling strategy.
• Manage labelling updates by critically assessing data and principles for clinical relevance and regulatory acceptance across the product portfolio.
• Chair the Product Labeling Team, determining appropriate team composition and involving necessary stakeholders from Global Medical, Clinical Services, Global Product Safety, and Clinical Safety to verify labelling content. Escalate unresolved issues to the Global Labelling Committee for final endorsement.
• Stay commercially aware of competitor labelling and evolving external trends and regulatory expectations.
• Resolve complex regulatory and scientific challenges, manage multiple concurrent projects, and apply sound judgment in problem-solving.
• Influence internal guidelines and regulations to positively impact external environments.
• Represent the company at industry forums such as DIA, Navitas, trade associations, and regulatory agency events, including workshops and advisory committee meetings with EMA and FDA.
• Review and approve promotional materials concerning core company documents and compliance with company codes and advise strategically on competitor labelling reviews.
• Potential responsibility for managing team members, including recruitment, motivation, and leadership within the labelling function, contributing to organizational governance through the Global Labelling Committee.

Candidate Requirements

• A bachelor’s degree in science, medicine, pharmacy, or a related discipline, with substantial labelling experience; advanced degree preferred.
• Leadership experience or readiness to supervise direct reports.
• Strong regulatory expertise encompassing labelling knowledge and familiarity with Global Labelling Committee processes and both EU and US regulatory frameworks.
• Excellent interpersonal, presentation, and communication skills to influence within complex, matrixed organizations.
• Aptitude to devise innovative and compliant labelling solutions aligned with business objectives.
• Ability to function independently and manage personnel according to organizational policies and legal requirements.
• Capability to interpret complex scientific data, author technical documentation, and articulate abstract concepts to senior executives.
• Proficient analytical and reasoning skills for solving moderately complex issues and drawing informed conclusions.
• Comfortable with fundamental mathematical calculations such as percentages, ratios, and rates.