Life Science Regulatory Services Associate

1 - 5 years

0 Lacs

Posted:3 weeks ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a LifeScience Regulatory Services Associate at Accenture, you will be part of the Life Sciences R&D vertical, contributing to regulatory services for leading biopharma companies. Your role will involve performing regulatory affairs LCM with Veeva skill set, submission in accordance with ICH guidelines, and reviewing and transforming source documents. Additionally, you will be responsible for performing Quality Control checks for all submission components, collecting and evaluating scientific data, advising on legal and scientific requirements, and ensuring compliance with current regulations. Key Responsibilities: - Perform regulatory affairs LCM with Veeva skill set of submission in accordance with ICH guidelines and other Health Authorities - Review and transform Source Documents - Perform Quality Control (Document QC) checks for all submission components - Collect, collate, and evaluate scientific data gathered as part of R & D - Advise on legal and scientific restraints and requirements - Ensure the organization`s products comply with current regulations - Build regulatory submission strategy, author CMC documents, and health authority packages Qualifications Required: - Master of Pharmacy In this role, you will be expected to solve routine problems with guidance from general guidelines, interact within your team and with your direct supervisor, and receive detailed instructions for daily tasks and new assignments. Your decisions will impact your own work within a predetermined scope as an individual contributor in a team setting. Please note that this role may require working in rotational shifts.,

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Accenture logo
Accenture

Professional Services

Dublin

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