Senior Director Regulatory Affairs

Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.We have a newly created a high-impact leadership role for a senior Regulatory Affairs professional who wants to shape strategy, influence clients and drive business growth. Acting as Deputy to the Regulatory Affairs function, you will be a trusted regulatory partner to both internal stakeholders and global clients, leading the delivery of complex regulatory projects from strategy through to execution. You will play a pivotal role in guiding regulatory pathways for marketing authorisations and managed access programs, while also supporting business development by helping win and grow client relationships. Combining deep regulatory expertise with commercial awareness, you will translate regulatory intelligence into clear, actionable advice that enables compliant, timely access to medicines and supports Clinigen’s continued growth.OperationalAct as the deputy for Regulatory Affairs function.Assist in managing the workload and resource levels needed to support the business division.Represent Clinigen professionally in external meetings in a variety of contexts (regulatory authorities, conferences, business meetings).Delivery of department-relevant projects to meet business needs.Responsible for allocated products including applications for marketing authorizations in new territories and maintenance of existing licences.Responsible for the provision of regulatory affairs support for allocated projects such as Managed Access programs, commercial partnerships, standalone projects.Responsible for supporting regulatory Due Diligence of potential acquisitions/partnered product opportunities etc.Responsible for supporting the development of regulatory strategies and provision of regulatory advice internally and externally.LeadershipSupport the operational growth and expansion of the PV/MI/RA division in line with the company’s strategy.Develop and nurture the Regulatory Affairs team to consistently provide high standard regulatory support across all business divisions.Be a key client contact to represent Clinigen externally and deliver client projects.Promote and act to protect patient and public health and regulatory compliance.Regulatory Intelligence and ComplianceEnsure that all regulatory activities comply with current Regulatory Agencies’ requirements and guidelines.Support the maintenance the Regulatory Intelligence repository for the supply of unlicensed medicines.Ensure Regulatory Intelligence updates are effectively communicated within the company highlighting business impact to help ensure regulatory compliance and proper planning.Proactively builds/strengthens contact with external stakeholder (Regulatory Agency, external experts, commercial partners etc.) to help achieve strategic goals and objectives.Contribute to company SOPs for PV/MI/RA.RequirementsBachelor's Degree in Life Sciences or scientific disciplineSignificant experience gained working in Regulatory Affairs within pharmaceutical industry/CRORelevant experience in a client facing roleWide experience and knowledge of Regulatory Affairs with an excellent grounding in European procedures and ideally exposure to medicines access i.e. expanded access/compassionate use/ drug development or RoW experienceUnderstanding of clinical research and clinical trialsDemonstrate ability to deliver results to the appropriate quality, budget and timeline metricsProven ability to successfully manage global regulatory projectsProven ability to provide coaching, advice and mentoring in areas of Regulatory AffairsExcellent organisational and project management skillsConfident dealing with managers and employees at all levelsOutstanding written, verbal and interpersonal communications skillsExcellent ability to handle multiple tasks in a fast-paced and constantly changing environmentAbility to be effective in the business development setting, with strong presentation skillsEffective communicator and influencer across all mediumsBenefits27 days holiday, plus bank holidaysDiscretionary BonusPrivate HealthPension contributions & Life Assurance schemeFlexible Benefits PlatformAnnual salary reviewIndependent financial advice serviceEnhanced Employee Assistance ProgrammeShopping discounts with retailersLong service awardsRecognition scheme & employee of the year awardsInterested? We would love to hear from you, please apply today for consideration.