Job title: Assoc Dir, Reg Affairs
Job description: JOB DESCRIPTION Required knowledge, skills and abilities . Experience in driving Labelling Centre of Excellence vision and goals . Subject Matter Expert in pharmaceutical product labelling . Ability to provide strategic input to develop technology-e
JOB DESCRIPTION Required knowledge, skills and abilities . Experience in driving Labelling Centre of Excellence vision and goals . Subject Matter Expert in pharmaceutical product labelling . Ability to provide strategic input to develop technology-enabled labelling services . Ability to provide strategic input to expand GRA labelling capabilities . Ability to provide strategic input based on planned and draft regulatory changes related to labelling (e.g. move to electronic Product Information) . Proven expertise in global labelling processes (including European Centralised, Mutual Recognition and Decentralised Procedure requirements for MAAs and variations) from initial change request through to implementation in the local market . Proven expertise in global labelling outputs, including Company Core Data Sheets (CCDS), justification document, Reference Safety Information (RSI), basis and reference labels, core and local labelling including artwork . Proven expertise in CTD Module 1 Product Information and Module 2.5 (clinical overview addendum) . Proven expertise and experience in chairing Global Labelling Committee meetings for the review of CCDS and RSI . Good understanding of US labelling requirements, including SPL format . Good understanding of process for preparation of initial CCDS from clinical trial data and Target product profile . Good understanding of pharmacovigilance activities related to Reference Safety Information for marketed products . Proven expertise for regulatory review of promotional material (AdPromo) for local market . Prepare and provide labelling training, including AdPromo for both regulatory and medical reviewers . Preferably, experience in labelling technology systems e.g. ZINC for AdPromo review and approval, RIM system with Labelling Module . Line Manager for supporting global labelling strategic projects Minimum required education and experience . Degree in life science-related discipline or professional equivalent plus at least 12 years regulatory experience, including 6-8 years labelling experience (or similar skill set) Soft skills . Self-motivated individual . Excellent communication skills (verbally, written and providing clear progress updates) . Open and communicative personality . Ability to drive a programme of work . Be able to manage peaks of workload and prioritise workload with minimal supervision for self and assigned project team members . Ability to work to tight timelines . Line management skills . Strategic management skills . Good team player . Good negotiating skills . Be able to identify and resolve issues, using flexible adaptable approach . Strong computer skills, including MS Office applications, data and document management systems . Adaptable to change 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: Sat, 26 Feb 2022 23:53:43 GMT
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