We have an exciting new opportunity to join BioIVT’s Senior Management Team in the role of Senior Director Regulatory Affairs and Quality Assurance, reporting to Vice President of Global Quality and Regulatory Affairs. Why Join Us? At BioIVT, you will be a part of a highly experienced, passionate team that is revolutionizing the biospecimen and research industry. You will have the opportunity to oversee all global regulatory efforts, regulatory systems management, process optimization, and data analytics and a team of seven subject matter experts and therefore directly contribute to the success of clients and BioIVT's growth. What You’ll Do Lead and SME on all matters related to Data Privacy and GDPR. Provide expertise in Cell and Tissue Based regulations and pharmaceutical products leading to the development and commercialization of Cell and Gene Therapies, Biologics and related pharmaceutical products. Ensure continuous compliance of BioIVT RA operations across diverse regulatory landscapes on a global scale. Oversee RA delivery across multiple countries, leveraging both internal expertise and external vendor resources. Develop and execute a robust RA data management strategy, while ensuring the integrity and efficacy of RA data analytics and reporting, facilitating informed decision-making on vendor performance, budget allocation, and compliance measures. Lead the strategic management of all RA systems, from conception to implementation and maintenance, ensuring alignment with business objectives and budgetary guidelines. Manage the global RA vendor strategy, overseeing vendor performance to ensure alignment with business needs, compliance standards, and budgetary goals. Monitor regulatory changes particularly with regard to the changing landscape of Data Privacy, assessing the impact on operations and devising strategies to mitigate risks and capitalize on opportunities. What you’ll bring (minimum requirements) BSc degree in life sciences (MSc or higher degree is preferred). Extensive work as a regulatory professional across diverse regulatory landscapes. Demonstrated acumen of managing and leading Regulatory Operations and global/matrixed function and teams. In-country or above-country RA experience in UK/EU or Canada. Experience of vendor oversight and outsourcing delivery models. Excellent knowledge of regulatory systems, directions and guidelines. Strong leadership and problem-solving skills. Excellent communication skills and ability to engage with Senior Leaders within the organization effectively. Ability to influence is paramount in this position. You will be dividing your time between the UK London and Burgess Hill offices as part of hybrid working, and will be traveling within the UK and EU with some reasonable travel to the US as part of this role. See the attached job description for further details. Apply Now and be a part of a company that's advancing precision medicine with innovative biospecimen solutions