IQVIA Regulatory Affairs Manager (Home-Based) - IQVIA Biotech in Boston, Massachusetts
Help create a healthier world: START RIGHT HERE AT IQVIA.
We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.
Please note this position is NOT related to study start-up but rather regulatory affairs dealing with applications to government authorities.
The responsibilities may include preparation of FDA meeting requests, meeting packages, preparation of responses to FDA questions, management, preparation and submission of initial IND applications and IND amendments to the US FDA. Preparation of CMC modules (small molecules and biologics both) of regulatory applications. May also include regulatory start-up activities such as identification of the central Institutional Review Board (IRB), Ethics Committee (EC), and essential regulatory documents required for multiple global projects, development of Regulatory Document Management Plan, review of initial regulatory documents for site activation, and maintenance of internal CTMS for tracking study site status site initiation through study maintenance. Manages project scope, timelines and budgets while serving as key source of communication to senior management ensuring their awareness of project status. Work directly with Director of Regulatory Affairs, Global Head of Regulatory Affairs, Director of Clinical Monitoring, EVP, Clinical Operations, Project Managers and Clinical Trial Managers in execution of multiple regulatory affairs projects. Assigned line management responsibilities.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Ability to travel domestically and internationally 10-15%
Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
BS in a health-related field (i.e. nursing, pharmacy, pre-medicine, clinical research) with at least 7 years of related experience in regulatory.
Within the total years of experience, at least 3 years within a management role and 2 years of supervisory experience is required.
Masters/doctorate degrees in a related field are preferred.
Pharmaceutical clinical research experience and electronic data management experience are required.
Must be familiar with and able to identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory bodies.
Must be able to independently coordinate with interdisciplinary team members, manage timelines for and compile documents for pre-IND and IND submissions, with oversight from Regulatory Management.
Excellent demonstrated knowledge of issues affecting regulatory affairs for clinical trials are required. Excellent written and verbal communication skills are required.
Documented continuing education in regulatory affairs or Regulatory Affairs Certification preferred
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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