Senior Regulatory Affairs Manager

Lead the preparation, submission and follow-up of regulatory applications to UK and Irish health authorities, so that vaccine approvals are secured and kept up to date Own the regulatory strategy for new approvals and ongoing changes, including support for product launches and the long-term management of the vaccine range Lead the yearly seasonal flu vaccine update process, making sure UK and Irish submissions are on time and the vaccine supply stays compliant each season Make sure all information sent to regulators is accurate, clearly presented and delivered on schedule Build strong working relationships with the vaccines business and global regulatory colleagues, aligning regulatory plans with business priorities Advise on how products are positioned and promoted, and contribute to commercial and operational planning from a regulatory angle Coach, develop and manage a small team, setting clear priorities and supporting their growth, while also covering for the Head of Regulatory Affairs when needed Minimum experience: 8-10+ years in regulatory affairs overall, including at least 3-5 years in a people-leadership capacity. Proven hands-on experience in UK regulatory affairs for biologics, including managing the lifecycle of a product portfolio (for example variations, renewals and submissions through national and European routes) A track record of leading and developing a team, with the ability to coach, motivate and set clear priorities Sound judgement in handling manufacturing and supply changes, balancing regulatory compliance with business needs Strong stakeholder management and communication, with the confidence to influence health authorities, business partners and cross-functional colleagues A life science or chemistry degree, or equivalent practical experience in a related field Fluent English, both written and spoken, as accurate communication is critical for regulatory submissions As Senior Regulatory Affairs Manager within our UK