Senior Director/Vice President of Quality, Pharmacovigilance and Regulatory Affairs

Senior Director/Vice President of Quality, Pharmacovigilance and Regulatory Affairs Role Location Newcastle, UK (or Remote UK) Role reports to CEO Company Description Shield is a commercial stage specialty pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol). The Group has launched Accrufer® in the US. Feraccru® is commercialized in the UK and European Union by Norgine B.V., who also have the marketing rights in Australia and New Zealand. Shield also has an exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialization of Accrufer® / Feraccru® in China, Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. in the Republic of Korea, VITAL-NET in Japan, and with KYE Pharmaceuticals Inc. in Canada. Accrufer®/Feraccru® (ferric maltol) is a novel, stable, non-salt based oral therapy for adults with iron deficiency, with or without anemia. Accrufer®/Feraccru® has a novel mechanism of action compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about Accrufer®/Feraccru®, including the product label, can be found at: www.accrufer.com and www.feraccru.com. Quality & Regulatory Defining the regulatory and operational strategies to achieve full regulatory approval for products within the pipeline as well as maintaining product registrations globally, in conjunction with partners as applicable. Providing advice to the Company and Board on Clinical, regulatory and Quality strategy, design and implementation. Maintaining oversight of the Quality Management System (QMS) to ensure compliance with GxP functions. Providing regulatory expertise on all clinical trial applications, marketing applications/authorisations, applications for variations, line extensions, amendments and renewals of existing clinical trial and/or marketing authorization, and responsibility for responding to any requests for scientific advice made from regulatory authorities. Communicate national and international regulatory matters effectively to Shield Executive Team (SET) and wider Company. To include identifying and communicating any material changes in regulatory requirements and emerging regulatory amendments which may impact on the Company either positively or negatively. Lead all Company discussions with regulatory agencies in the US and, as appropriate, either lead or support partner discussions with other relevant regulatory, health authorities and trade associations globally. Ensure effective support and appropriate regulatory guidance is provided regarding requirements throughout the product lifecycle in line with corporate strategies. Ensure effective support and appropriate oversight of partner clinical, registration and life-cycle strategies and operations Responsible for ensuring the Company complies with all current regulatory requirements, to include reviewing guidelines, regulations, regulatory journals, networking with regulatory peers, reviewing and maintaining a system of regulatory intelligence in order to monitor activities of competitors. Management of Quality, Pharmacovigilance and Regulatory Affairs teams to ensure compliance with relevant GxP regulations. Pharmacovigilance and Clinical Management oversight of the global Pharmacovigilance function, run operationally by the Head of Pharmacovigilance. Oversight of scientific/ clinical development strategy and plans for all Company assets, in conjunction with external clinical consultants and internal Medical Affairs, as appropriate. Represent Shield Therapeutics from a scientific perspective at meetings with medical experts and advisory panels, principal investigators, regulatory authorities, potential alliance partners and the investor community, with appropriate external and internal medical input as required. Ensure any partner clinical programmes are carried out in accordance with Company strategy and according to ICH-GXP Ensure clinical documentation on file/archived (in particular paper and electronic Trial Master Files [TMFs]) are stored and maintained in accordance with GCP. Required Skills & Experiences In-depth knowledge of major regulatory authority regulations and understanding and usage of medical terminology Understanding of Quality, Pharmacovigilance, and clinical development principles and functions Post-graduate regulatory experience leading to a higher-level qualification such as an MD or PhD preferred Experience in several of the key therapeutic areas (hematology, women’s health, GI, CKD) Experience of effectively leading face-to-face interactions with relevant regulatory authorities, in particular the US FDA, at key stages of development i.e. scientific advice meetings, IND meetings, end-Phase II/III meetings, advisory committees, etc. Solid track record in Regulatory Affairs with significant clinical development experience and demonstrated ability to build effective relationships with knowledge leaders in the US and Europe. Significant management experience with a proven ability and desire to develop and lead people. A hands-on, self-starter who is energetic, resilient and uncompromising in the pursuit of excellence and delivery of agreed goals. Creative problem solver with a ‘can-do’ approach who has the ability to proactively develop and implement effective alternatives to current programmes. Excellent team player with the ability and desire to coordinate with the other members of the management team. Excellent communication abilities including presentations, leading meetings and well-developed writing skills. Possess sufficient stature, quality, experience, personality and management skills in order to be capable of liaising with the Board and the external community. Strong organisational and project management skills. #J-18808-Ljbffr