Regulatory Affairs Officer 2

Iqvia Holdings Inc San Diego , CA 92140

Posted 2 months ago

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Job Profile: Grade 140 Reg Officer 2 - US Maintenance GRL

Expertise

Degree in life science-related discipline or professional equivalent
Minimum of 3 years in US regulatory lifecycle maintenance experience, focusing on US marketed products

Technical Experience

Experience in regulatory procedures in the US within regulatory lifecycle maintenance activities including Annual Report authoring and co-ordination, knowledge of IND, NDA, BLA applications working cross-functionally with other regulatory stakeholders e.g. Global Regulatory Lead (GRL), CMC, Labelling, Non-Clinical, Clinical, Publishing etc.
Preferably has experience in managing small regulatory projects
Interaction with Regulatory Agencies i.e. FDA is desirable but not a must
Involvement in regulatory strategy and determination of documentation requirements, timelines, budgets
Experience in quality review of technical / regulatory documents
Experienced working in regulatory electronic systems such as RIM, document management systems (EDMS), publishing viewer
Able to assist in review and revision of regulatory and client SOPs / act as reviewer as appropriate

Core responsibilities

Coordinate several US Annual reports (AR) for IND, NDA, BLA applications to be submitted to FDA for the marketed products portfolio involved in notification, preparation, authoring, compilation and final publishing working cross-functionally with the client GRLs and Functional Area Leads (FALs)
Arrange, prepare content and lead Kick-off meetings per AR with FALs discussing timelines, roles and responsibilities, issues etc.
Draft cover letters, forms, document plans required for submission
Ensure electronic databases, trackers and systems for product portfolio are appropriately managed and maintained in a timely and organized manner
Escalate issues early to the Workstream lead mitigating risks
Provide support to the Workstream lead, as needed

Soft Skills

Excellent verbal and written communication skills in English are essential
Well organized
Be able to manage peaks of workload and prioritize workload with some supervision
Ability to work to tight timelines
Open and communicative personality
Good team player
Good negotiating skills
Ability to identify issues and contribute to their resolution
Strong computer skills, including MS Office applications, project management tools (trackers), data and document management systems, SharePoint
Adaptable to change
Cultural awareness

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.

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