Overview

Global Head of Regulatory Strategy & Labelling role at Mundipharma. Location: Cambridge, Hybrid - Open to remote working. Department: Regulatory Affairs. Job type: Full Time.

Role and responsibilities

The Global Head of Regulatory Strategy & Labelling will join the Senior Leadership team in Regulatory Affairs and be accountable for global regulatory strategic leadership and CCDS and labelling updates. The role ensures efficient leadership, management and delivery of regulatory strategy and labelling strategy for the full portfolio across the product lifecycle, and oversight of the internal RA strategy lead team and outsourced RA activity.

• Accountable for overall Regulatory Strategy for all products including deployment of regulatory expertise to meet portfolio deliverables; accountable for regulatory stewardship of assets in clinical development and labelling strategy across lifecycle.
• Lead the execution of regulatory strategy; produce global regulatory strategy plans for all products in the portfolio.
• Engage with stakeholders and senior leaders to develop regulatory strategies aligned with commercial goals; engage external experts/consultants as needed.
• Ensure regulatory strategies recognize risk, provide mitigations, and are communicated for decision-making.
• Engage with Regulatory Authorities to reflect regulator feedback in strategic and tactical plans.
• Oversee regulatory contribution to promotional materials; represent Regulatory as core member of the Signal Evaluation and Labelling Group; provide regulatory intelligence.

What you’ll bring

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

What we offer

• Flexible benefits package
• Opportunities for learning and development through our programmes
• Collaborative, inclusive work environment

Diversity and inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We are on a journey to move forward together through education and awareness to build a culture that welcomes and celebrates diversity. We will create a workplace where everyone can bring their authentic selves and is treated with dignity and respect.

About Mundipharma

Mundipharma is a global healthcare company focusing on customers across Africa, Asia Pacific, Canada, Europe, Latin America and the Middle East. We are dedicated to bringing innovative treatments to patients in areas including pain management and infectious disease. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of what we do. For more information visit www.mundipharma.com.

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Additional job information

Primary Location: GB Cambridge

Job Posting Date: 2025-09-05

Job Type: Permanent