Essential Functions:

12-month fixed term contract.

Regulatory Strategy:

Provides input to global program regulatory strategy, including regulatory designations & innovative approaches

May provide global RA leadership for specific part of the program e.g. new indication, new formulation or act as RA program lead for program of limited complexity

Coordinates regulatory readiness with other line functions, Country Organizations & Regions

Represents RA or leads in regional RA or cross-functional activities

Provides strategic input to cross functional deliverables (e.g. protocols, IB, safety reports etc)

Contributes to the development and maintenance of the Core Data Sheet (CDS)

Determines requirements and coordinates activities for Health Authority (HA) interactions.

May lead HAs meetings together with RA program lead.

May serve as local HA liaison (e.g., FDA or EMA).

Regulatory Submissions

Leads planning, preparation and submission of clinical trials.

Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.

Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents

Contributes to preparation, review and maintenance of local product information in their assigned region

Leads regulatory activities during HA reviews including response to questions and HA interactions Regulatory Excellence and Compliance

Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions

Maintains regulatory information in compliance databases and document management systems

May serve as RA subject matter expert

Qualifications:

Bachelor's degree preferred (Minimum/desirable)

Science based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred

Advanced understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific data

Awareness of post-marketing/brand optimization strategies and commercial aspects.

≥4 years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region.

Experience in leading cross-functional teams

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com