Job Title: Global Regulatory Affairs Lead (GRL), Pharmaceutical Diagnostics
Location: London, UK / Germany/ Sweden/ The Netherlands/ Greece/ Switzerland & Belgium
Salary: Attractive salary plus benefits package
Working 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, of pharmaceutical diagnostics. You will be ‘the face’ of the Global Regulatory function on cross-functional global project teams for new product introductions and single point of accountability for Global Regulatory Strategy Leadership and policy development.
You will sit within the Pharmaceutical Diagnostics division the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.
Role responsibilities:
· Drive global Regulatory Affairs strategies for the Diagnostic portfolio, including managing internal and external stakeholders.
· Lead interactions with the health authorities – MHRA, EMA & FDA.
· Support development activities CTAs, PIPS, IND, IMPD, and initial MAAs.
· 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.
· Fulfilment of regulatory compliance obligations.
· Manage lifecycle maintenance activities.
Requirements:
· Proven track record of leading successful European (CP, DCP, MRP), European national and US NDA/BLA licensing submissions.
· 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.
· Knowledge of preclinical, CMC, clinical related regulations/guidance as it relates to development product submissions.
· Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs.
· Ability to clearly convey and exchange information with internal and external stakeholders.
This role will be responsible for leading the EU Regulatory Team across multiple geographies, providing support, mentorship, and advice in a challenging regulatory environment. 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