Sr Regulatory Affairs Officer (Home-based, East Coast)

Position Purpose:
•    The IQVIA Regulatory Intelligence service provides the pharmaceutical and medical device industries with easy access to original and translated regulatory documents, summarized regulatory intelligence and comparative tables with up-to-date key regulatory requirements worldwide.
•    The US Regulatory Subject Matter Expert role requires extensive knowledge and experience of the US New Drug Application (NDA)/abbreviated NDA and Orphan Drug Designation submission (content, dossier requirements, timelines, format, submission pathways and  processes) and packaging and labelling requirements gained within a pharmaceutical and/or consultancy environment.
•    The US Regulatory Subject Matter Expert will collaborate closely with a broad network of internal and external specialists for both maintenance of the US regulatory content within IQVIA Regulatory Intelligence Database and expansion and development of regulatory affairs content as part of content expansion project teams

Principle Accountabilities:
•    Working within cross-functional teams and in collaboration with a network of internal/external regulatory experts. to ensure production of high-quality (timeliness, completeness and accuracy) regulatory intelligence related to regulatory affairs as per defined QMS processes.
•    Providing regulatory knowledge to support enquiries from customers, sales, marketing and business development.
•    Support knowledge sharing and management activities within IQVIA Regulatory Intelligence by providing advice and input on the external regulatory environment
•    Proactively input to regulatory content development projects:
o    Identify opportunities for content improvement/enhancement projects related to regulatory affairs 
o    Contribute to the scope, content identification, user requirements and content creation as well as supporting the QC of the content prior to launch.  
o    Work in collaboration with other cross-functional team members to design and plan editorial processes and tools to maximize the delivery and quality of  regulatory intelligence
•    Contribute to raising visibility of IQVIA Regulatory Intelligence services and talent externally (e.g. publications, presentations).

Experience and Skills Required:
•    Proven experience and tenures working in Regulatory Affairs within Life Sciences (within regulatory authority, consultancy or industry) in the US.
•    Degree in life sciences and supplementary education with a regulatory component would be an advantage
•    In-depth knowledge of regulatory requirements related to regulatory procedures and pathways, submission content, dossier requirements and packaging and labelling requirements for US and other key markets globally with practical experience and understanding of regulatory strategies.
•    Knowledge or experience of using regulatory intelligence services within the regulatory affairs environment.
•    Ability to understand and interpret regulatory developments (guidelines, regulations and laws) to understand, anticipate, interpret and communicate regulatory trends and requirements
•    Understand potential impact of regulatory developments on client products and regulatory business processes 
•    Knowledge/experience of US Scientific Advisory Committee activities and other US regulatory requirements for safety, clinical, good manufacturing practice or medical devices would be an advantage.
•    Knowledge of IT systems used within regulatory, safety, clinical or quality (validated systems) and regulatory intelligence would be an added advantage.
•    Experience working in a project environment with demonstrated ability to plan, manage and drive project contributions to ensure delivery of high-quality content in a timely manner
•    Strong attention to detail, proactive and highly organized
•    Knowledge of quality management within Life Sciences
•    Business understanding/acumen
•    Ability to create strong working relationships within the IQVIA Regulatory Intelligence team and across the organization 
•    Self-motivated, enthusiastic and hard-working
•    Strong analytical, organizational and problem-solving skills
•    Ability to communicate clearly and effectively (verbally and written) and experience in writing summaries/reports for different audiences

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 workday_recruiting@iqvia.com to arrange for such an accommodation.