Director Regulatory Science - Life Cycle Management (LCM) Europe

Orchard Therapeutics ,
London, Greater London
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Director Regulatory Science Life-Cycle Management Europe Location: London Reporting to: VP, Regulatory Science The Company: Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically-modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. With a commercial product already, the company has one of the deepest gene therapy pipelines in the industry and is advancing seven clinical-stage programs across multiple therapeutic areas, including inherited neurometabolic disorders, primary immune deficiencies and blood disorders, where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist. Orchard has offices across the US and Europe, including London and Boston. For more information, please visit www.orchard-tx.com, and follow us on Twitter and LinkedIn. Job summary Within the Regulatory Science department, the Director Regulatory Science Life-Cycle Management Europe will lead the regulatory activities linked to the launch & or life-cycle management (LCM) of Orchards approved gene therapy medicinal products in the EU. For any LCM activity, this consists in defining the strategy and implementing it, working internally with the program teams and externally with EMA and any relevant service providers. Requirements Key Elements and Responsibilities Under the guidance of the VP Regulatory Science, the Director Regulatory Science Life-Cycle Management Europe will: * Be involved in all life-cycle management activities necessary to maintain the registration of approved products i.e. will define the activities to be conducted (variations, PAM, PBRER), define the strategy to be applied, prepare the relevant regulatory submissions and manage their submission until approval by the regulatory agencies (EMA). * Support EU affiliates and act as reference person for all regulatory matters related to the launch and maintenance of these products on the local EU member states (working with local regulatory consultant as & when needed) * Participate in the relevant program team meetings and discussions and represent the Regulatory Science department. Ensure optimal execution of the regulatory strategy agreed with the program teams. * Participate in the implementation and maintenance of the risk minimization measures and manage the regulatory documents forming the educational and controlled distribution programme * Contribute as needed to discussions with European regulatory authorities, national EU authorities and/or industry associations. * In any activity, ensure compliance with relevant regulations and regulatory guidance as relevant * Be responsible for the tracking of all regulatory events (submissions, questions, approvals, ) and commitments throughout the product lifecycle as well as for appropriate management of all related regulatory documents * Participate actively in the regulatory intelligence. Monitor, analyze and disseminate EU regulatory news linked to LCM activities [e.g. on Brexit]. * Provide support to improve team standard operation procedures by authoring new SOP or editing existing SOP * Substantial experience of regulatory registration, launch and maintenance of the license of centrally approved medicinal products in the EU (including at the local level), acquired within industry (big or small) or consultancies * Proven knowledge of the registration and LCM of orphan medicinal products in the EU * Previous experience of working interactions with EMA and EU national authorities * Knowledge of ATMPs (including gene therapy) desirable. Experience of development or registration of cell or gene-based therapy is a plus * Able to work autonomously * Strong project management skills * Strong interpersonal skills including excellent verbal and written communication * Capable of critically reviewing complex technical documents and ability to interpret regulatory requirements for medicines in Europe together with the awareness of the commercial implications of pharmaceutical regulation. * Strong attention to detail and the ability to handle multiple task and multiple stakeholders to achieve the business objective * Comfortable working in a fast-paced and constantly evolving environment and able to adjust workload based upon changing priorities * Excellent organizational, computer and documentation skills and an ability to prioritize effectively * A Pharm D. or equivalent advanced degree in life sciences. Required knowledge Skills & Abilities Education Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. Notice to All Applicants: Orchard Therapeutics participates in E-Verify RECRUI

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