Job title: Regulatory Affairs Officer
Job description: JOB DESCRIPTION Essential Functions Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amen
JOB DESCRIPTION Essential Functions Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc. Support Regulatory Affairs personnel in the coordination, preparation, and submission of all above submissions. Responsible for the pre-publishing (Bookmarks and Hyperlinks), compilation, post publishing, Validation of Regulatory submissions and lifecycle management submissions. Identifies project needs, tracks project timelines, implements client requests and manages dayto-day workload in collaboration with senior staff, as appropriate Perform QC process to ensure the integrity and quality of each published unit. Planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic formats. Responsible for maintenance of all Regulatory and FDA correspondence (distributing, filing into electronic document management system) within specified time frames. Liaise with functional source areas (clinical, nonclinical, CMC, regulatory) to ensure documents are compliant with authoring style guide. ‘Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications’. Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters. Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the US FDA, EMEA and ICH. May represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents. Keep close interaction with authoring community to track availability of deliverables. Technical knowledge of electronic publishing systems and software (RIM Smart, Insight, eCTDXpress, Extedo, Lorenz) May prepare and deliver trainings, as appropriate. Proficiency with MS-Office Suite and Adobe Acrobat applications, Knowledge of Electronic Document Management Systems. Responsible in solving day to day queries of the team members. Self-starter with superior time management skills, and ability to work independently or in teams Performs other tasks or assignments, as delegated by Regulatory management Qualifications Relevant Experience: 3.5 to 7 yrs. Life Science background (BSc to MSc, Bpharm) IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at
Location: Bangalore, Karnataka
Job date: Thu, 10 Mar 2022 23:41:04 GMT
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