Director Global Regulatory Affairs

North Search

is a leading international

talent consultancy , partnering with organizations across rapidly changing sectors to deliver outstanding talent and innovative leadership.

We are excited to announce a unique opportunity with one of Europe’s foremost Pharma groups. The

Global Regulatory Director

is responsible for leading and developing the Regulatory Affairs function across the Global scope. This role plays a critical part in ensuring regulatory, managing risk, and enabling business growth by leveraging an evolving regulatory landscape. The incumbent will guide cross-functional teams on compliance matters related to raw materials, formulation, product, claims, and finished goods specifications, while fostering strategic partnerships with external regulatory bodies and industry groups.

Key Roles

responsibilities :  Build and manage a high-performing Regulatory team, fostering capability development, cross-training, and succession planning.  Lead all local and global regulatory activities in alignment with the company guidelines.  Develop and execute long-range strategic direction for the Regulatory function in support of business goals, leading and coordinating regulatory activities, working with distributors and affiliates to speed up the registration, aligning processes and systems to ensure consistency between Regulatory strategies and business priorities.  Oversee regulatory compliance for raw materials, finished goods specifications, claims, labelling, and trade law across the region.  Accountable for “Right First Time” documentation of drug specifications and API´s.  Customer-facing technical documentation (accurate, timely, and compliant with EU regulations)  Proactively monitor regulatory trends, changes, and competitor intelligence in the EU region, communicating key insights and implications to global stakeholders.  Develop sound regulatory strategies and risk mitigation plans aligned with product portfolios and innovation pipelines.  Respond to regulatory inquiries from customers with speed, accuracy, and professionalism.  Engage and build partnerships with regulatory authorities, government agencies, NGOs, industry associations, and lobby groups to shape and anticipate regulatory developments.  Drive process simplification and standardization by leveraging digital tools and IT systems for regulatory documentation, licenses, and compliance workflows.  Supervise and develop regional Regulatory team members with responsibility for recruitment, performance management, training, and development.  Foster a collaborative and inclusive team culture.  Expert knowledge of EU and regional pharma regulations.

Your qualifications Bachelor’s or Master’s degree in Science, Regulatory Affairs, or a related field. 10+ years of progressive regulatory experience in the Life Science Industry (Pharma ethical products). Previous experience in the preparation and submission of MAAs or major Type II Variations/Line Extensions. Excellent organisational, computer (digital and AI is a plus). Significant leadership experience in a multinational role. Proficiency in English

Ready? North Search and our client are committed to fostering a

diverse, equitable, and inclusive workplace . We encourage applications from professionals of all gender identities, backgrounds, and abilities. Take your career to the next level—apply or contact us for more informatio n.