Senior Director, Regulatory Affairs - Iqvia Biotech

This role is critical to lead the global Regulatory Affairs team requiring broad management and leadership skills across several billable areas. This involves recruiting a knowledgeable individual to lead multiple job areas with the ability to influence others to accept IQVIA practices and Biotech approaches on sponsor studies. Successful candidate should possess over 10 years' relevant experience (at minimum) gained from deep domain knowledge acquired from covering Clinical/Development & Strategy - Scientific Advice meetings with the Regulatory Authorities, across numerous Therapeutic Areas. Orphan Drugs/Rare Diseases experience desirable.

The successful candidate needs to be strong in Regulatory Affairs Strategy, Tactics, and Implementation; possess working knowledge of Regulatory Intelligence; and spectrum of experiences supporting clients and taking products through Early and Late Phase, through to successful Registrations and Post marketing across Therapeutic Areas. Additionally, possess good commercial awareness and understanding of how the business works, plus how Regulatory matters can impact on 'the bottom line'.

Responsibilities will include Line Management responsibilities for multiple Regulatory Affairs sites and/or region. Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs and Corporate business plans. Mentoring and leading Regulatory team (Directors and Staff) in addition to leading major project works in Europe and North America, as necessary. Accountabilities for Regulatory Affairs Strategy, Tactics, and Implementation. Ideally, possessing good working knowledge and experience of: Phases I to IV: Clinical/Development Regulatory Affairs; Registrations and Post approval: CTA's, IND's, IMPD's, IB's, Protocols, updates/amendments and End of Trial Notifications/other Development Regulatory activity, CTD/Dossiers for MAA's (overseeing all Modules 1 to 5); National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib, II and III Variations and Renewals; Labelling, PIL's and SmPC's. PSUR's. Scientific Advice meetings and PIP's/Waivers.

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.