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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