Job Title: Global Regulatory Affairs Lead (GRL)Job Type: Full-time permanent positionLocation: UK or Europe – Hybrid/remote-based roleSalary: Attractive salary plus benefits packageWorking for one of the industry’s leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge from pre-clinical through clinical studies to initial registration in key global markets. You will be ‘the face’ of the Global Regulatory function on cross-functional global project teams for new product introductions and a single point of accountability for Global Regulatory Strategy Leadership and policy development.The business is looking for someone who is confident in phase 3 of drug development and is successful in licensing new drugs into global markets. You will sit within the Pharmaceutical Diagnostics; however, will only be managing the molecule as opposed to the device. The business has assets ranging from pre-clinical through to late stage and you will be responsible for all regulatory activities related to your assigned assets.Role responsibilities:Lead all licensing/filling activities assigned to the development portfolio.Drive global Regulatory Affairs strategies for the portfolio, including managing internal and external stakeholders.Lead interactions with health authorities/local agencies – MHRA, EMA FDA, including pre-submission meetings, pre-IND meetings, scientific advice, and type B/C meetings with the FDA.Support both early and late-stage development activities CTAs, IND, ODD, PIPS, IND, IMPD, and initial MAAs.Confident in doing submissions in global markets with a main focus on the EU, US, and China.Working with NRA, ensure timely GRA input to global development programs.Support and lead cross-functional team discussions with medical, quality, PV, and other departments.Fulfil regulatory compliance obligations.Support assets from pre-clinical, phase 1, 2, and 3.Requirements:A PhD qualified profile is desirable but not a must.Proven track record of leading successful European (CP, DCP, MRP), European national and US NDA/BLA licensing submissions.Previous experience focused on phase 3 and leading licensing activities globally.Extensive initial MAA/NDA/BLA experience.Proven track record of leading successful interaction with HA and relevant stakeholders.Knowledge of regulatory frameworks and external environments as it applies to project-specific global regulatory strategy document (GRSD) delivery.Ability to drive new regulatory approaches to improve and expedite development product submissions to meet business/project objectives and patient needs.Ability to clearly convey and exchange information with internal and external stakeholders.This role is a very senior position within the regulatory team, and the business is looking for a wealth of experience across the drug development cycle. You will have a sound understanding of the Oncology space, be able to devise strategies in line with business requirements globally, and be able to influence at a high level internally and externally.For more information, please contact lucy.kirkaldy@cpl.com
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