Accenture Job Vacancy For Regulatory Affairs
Accenture is hiring for Regulatory Affairs who can fulfill the following criteria.
Location: Bangalore
Years of experience: 1.5 to 5 years in regulatory affairs in at least one regulated market region (e.g., US, Europe).
Roles & Responsibilities:
The incumbent will perform the regulatory affairs tasks like creation of granular level documents and Quality Checks of regulatory documentation.
This includes global and country-specific CMC/labelling documents and submission-ready components for major applications and lifecycle submissions. The role also reviews submissions to ensure eCTD standards per Health Authority regulations and guidelines are met, with focus on the technical metadata, submission content, and life-cycle management of the submission/application.With supervision, this role is expected to perform the following activities, depending on the project(s) assigned:
Assist with the filing and approval processes for investigational and marketed products.
Contribute to creation and review of CMC/ labeling documents.
Baseline maintenance of lifecycle management (post approval/renewals activity) submissions
Baseline/Document Management
Handle tools (like Veeva, Docubridge, RIMS, CARA, Trackwise etc.)
Conduct regulatory QC reviews of Module 1 administrative regional documents for accuracy and completeness.
Conduct regulatory QC of Module 2 summaries, Module 3 technical CMC documents, Module 4 preclinical reports and Module 5 Clinical Study Reports (CSRs).
Conduct review of complete IND, CTA application eCTD xml backbones for eCTD compliance and accuracy.
QC/Review IND, CTA documents to ensure they follow eCTD authoring granularity
Provide guidance and recommendations on content location within the eCTD structure.
Assure submission process and standards adhere to Accenture SOPs.
Work with team leader to establish individual goals to meet project timelines
Provides timely communication on status and/or issues
Interested candidates can share their updated resumes to rajeshwari.naidu@accenture.com with Subject line as RA
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