Global Head of Regulatory Strategy & Labelling

Global Head of Regulatory Strategy & Labelling

Location: Cambridge, Hybrid – open to remote working

Department: Regulatory Affairs | Job type: Full time

Posted: 2025-09-05 | Status: Permanent

Role and Responsibilities

The Global Head will lead global regulatory strategy and labelling across the full product portfolio. Key responsibilities include:

• Accountable for overall regulatory strategy for all products, ensuring alignment with CMC and market clusters.
• Stewardship of assets in clinical development and responsibility for labelling strategy across product lifecycle.
• Execution of regulatory strategy, revising plans as new data or commercial positions arise.
• Generate global regulatory strategy plans for all products in the portfolio.
• Engage stakeholders and senior leaders to develop strategies and deliver regulatory expertise aligned with commercial goals.
• Engage external experts and consultants to support strategic decision‑making.
• Identify regulatory risks, propose mitigations, and communicate them within the organization.
• Maintain optimal engagement with Regulatory Authorities to incorporate their feedback into product plans.
• Oversee regulatory contribution to promotional materials.
• Represent Regulatory in the Signal Evaluation and Labelling Group.
• Provide regulatory intelligence.

Qualifications and Experience

• Proven experience in Pharma Regulatory Affairs strategy and managing labelling activities.
• Track record of developing and executing innovative regulatory strategies with interactions with key Health Authorities (EMA, FDA, BfArM, MHRA, TGA, PMDA, etc.).
• Excellent regulatory strategist with strong commercial instincts and ability to deliver superior outcomes across a diverse portfolio.
• Strong understanding and expertise in Clinical Strategy.
• Demonstrated knowledge in labelling strategy and management of product labels across lifecycle.
• Excellent collaborator with strong customer and stakeholder focus.
• Ability to build relationships and inspire confidence at all levels, including senior leaders.

Benefits

• Flexible benefits package.
• Opportunities for learning & development through varied programmes.
• Collaborative, inclusive work environment.
• Diversity and inclusion commitment, fostering an environment where everyone can thrive.

About the Company

Mundipharma is a global healthcare company focusing on pain management, infectious disease, and other severe therapeutic areas. Guided by integrity and patient‑centricity, we bring innovative treatments globally.

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