Regulatory Affairs Strategy Leader

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Our client is a growing pharmaceutical client with a track record in UK, Europe and the US and international markets. They looking for a Regulatory Project Leader to join the team to help with the implementation of regulatory frameworks for drug development, submissions to markets and existing portfolio of products.Job Purpose:The Regulatory Project Leader will develop and lead global regulatory strategies and drive the execution of these strategies and plans for product development, to deliver successful approvals and launches of products for the business across the designated territoriesTo provide expert guidance and support to R&D and commercial team members for activities related to developing and enhancing the value of the pipelineThe Regulatory Project Leader will develop people through mentoring, coaching and acting as a role modelDevelop and improve procedures for the Regulatory Strategy group that improve efficiency and consistency across the departmentSupervisory Responsibility: None initially. Potentially applicable at a later date.To comply with all relevant GXP regulationsTo carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and othersTo comply with all Company policies and proceduresTo follow a code of conduct conducive to a professional environment Responsibilities: Act as the Regulatory Strategy Project Lead for assigned projectsProvide expertise on current drug development and marketing authorisation requirements and procedures to enable efficient product development and approval strategies, aligned with R&D and Commercial objectives, to deliver optimal labelling and market accessLead the development of robust Strategic Regulatory Plans for R&D projects and deliver regulatory milestones in accordance with the plansIdentify and assess regulatory risks and mitigation strategies associated with product developmentDrive the delivery of high quality submissions (CTA/IND, MAA/BLA) in a timely manner and manage the preparation and delivery of appropriate responses to agency review issues, delivering successful approvals that meet company objectivesLead interactions with Health Authorities including preparation of high quality briefing documents and development of robust company positions to enable successful outcomesMaintain and improve awareness of current and emerging regulatory and scientific guidance appropriate to R&D and provide expert advice on items or issues which will affect product development plansRepresent the company at relevant external meetings, including global regulatory HA meetings, scientific and HTA advisory boards and trade association meetingsReview department processes and develop procedures to enhance efficiency and effectiveness of the Regulatory Strategy and/or Regulatory Affairs departmentFacilitate teamwork, undertake mentoring and provide guidance to direct reports and team membersKey Performance Indicators:Delivery of high quality regulatory strategy plans for R&D product development, including risk assessment and mitigation plans, and milestone planning in accordance with the R&D RoadmapSuccessful execution in accordance with regulatory plans leading to timely submissions of clinical trial and marketing authorisation applications and core briefing packagesSuccessful, timely approvals that deliver optimal labelling and market access in the designated territoriesImplementation of new or revised processes that enhance efficiency and effectiveness of the Regulatory Affairs departmentQualifications/Experience required:Science degree or equivalent qualified.Regulatory experience in either biotech/pharmaceutical industry with a broad in-depth knowledge and experience of drug development and approval requirements for Europe and/or US.Experience with immunotherapy products would be an advantageProven experience of leading and managing successful drug development submissions and approvals, including CTAs/INDs and MAAs/BLAs/NDAsLeading company interactions with health authoritiesDeep understanding of relevant Regulatory Guidelines and legislation, including Europe, US and preferably other international territories.Experience with programmes and opportunities for accelerated development would be advantageous To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales