Director, Labeling Strategy

Accountabilities

• Labeling Strategy Leadership: Define and drive the labeling strategy in line with the product’s regulatory strategy by interpreting regulations, guidance and competitor labels; anticipate wider impacts and long-term consequences for the product and the broader portfolio.
• Advantaged Product Information: Lead Product Labeling Teams to prepare and maintain high-quality Core Product Information (CPI) and EU/US Prescribing Information (MPI) through senior leader approval to deliver advantageous labeling.
• Health Authority Negotiation: Shape labeling negotiation strategies, anticipate health authority perspectives and equip teams with clear rationales and risk mitigations to secure optimal outcomes.
• Expert Guidance to Key Teams: Provide labeling expertise to teams on language, placement and regulatory content for CPI and MPI in line with company procedures and regional labeling regulations and guidance.
• Clarity in Complexity and Risk Insight: Bring clarity in complex situations by outlining applicable requirements, highlighting risks and proposing pragmatic mitigations for stakeholders.
• Global Intelligence and Trend Scanning: Evaluate, interpret and communicate global regulations and labeling trends, translating them into business-relevant insights and actions.
• Target Product Labeling: Lead development of Target Product Labeling documents to align development plans and evidence generation with intended label claims.
• Process, Policy and SOP Stewardship: Contribute to the development of labeling documents, policies, procedures and SOPs and ensure the labeling process is followed across the product lifecycle.
• GxP and Compliance Ownership: Ensure all labeling work is performed in accordance with established procedures, regulatory requirements and GxPs.
• Leadership and Capability Building: Be a visible, approachable leader and role model; coach or line manage labeling team members; support hiring, training, coaching and career development; ensure appropriate labeling support across all allocated projects.
• Portfolio Planning and Governance: Partner with the Senior Director Group Manager on project and resource planning and effectively deputize as required to maintain momentum and quality.

Essential Skills/Experience

• Bachelor’s degree in science or related discipline with 5+ years of pharmaceutical experience, to include regulatory and labeling experience.
• Ability to assimilate clinical and scientific information and present it in a concise manner.
• Knowledge of labeling regulations and guidance.
• Excellent verbal and written communication skills.
• Keen attention to detail and accuracy.
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk.
• Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
• Competencies in building relationships, negotiation skills, critical information seeking, rational persuasion, interpersonal awareness.

Desirable Skills/Experience

• Advanced academic training is highly desirable (PharmD, PhD).

Pay

The annual base pay for this position ranges from $186,233 to $279,349.

Benefits

• Eligibility for various incentives—short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
• Qualified retirement programs.
• Paid time off (i.e., vacation, holiday, and leaves).
• Health, dental, and vision coverage in accordance with the terms of the applicable plans.