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Lifescience Regulatory Svs Associate

0-2 years
Not Disclosed
10 Dec. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Life Sciences Regulatory Services Associate

Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Experience Required: 0–2 years


Company Overview

Accenture is a global professional services company with leading capabilities in digital, cloud, and security. With specialized expertise across more than 40 industries, Accenture offers Strategy and Consulting, Technology, Operations, and Accenture Song services.

With a workforce of over 699,000 professionals serving clients in more than 120 countries, Accenture delivers innovative solutions that combine technology and human ingenuity, helping organizations achieve value and shared success. Learn more at www.accenture.com.


Role Overview

We are seeking a Life Sciences Regulatory Services Associate to join our Life Sciences R&D vertical. This role is ideal for Pharmacy graduates with 0–2 years of experience in regulatory operations, document publishing, or eCTD submissions.

The incumbent will support regulatory operations for global biopharma submissions, ensuring compliance with ICH guidelines and Health Authority requirements. This includes managing electronic submissions, performing document QC, and coordinating resources required for regulatory filings.


Key Responsibilities

  • Perform document QC (Quality Control) for submission components and review source documents for accuracy and compliance.

  • Execute electronic submissions, including original applications, Life Cycle Management (LCM) submissions (CMC, amendments, annual reports, Ad-promos, SPL submissions, etc.).

  • Bookmark and hyperlink granular components of submission dossiers according to regulatory guidelines.

  • Coordinate essential documentation and resources for filing global applications.

  • Apply regulatory operations knowledge to solve routine issues using standard guidelines and precedents.

  • Collaborate within the team and escalate issues to supervisors as required.

  • Maintain detailed records and documentation to ensure regulatory compliance.

  • Work efficiently in rotational shifts if required.


Qualifications & Skills Required

  • Bachelor’s degree in Pharmacy (B.Pharm).

  • 0–2 years of experience in regulatory operations, eCTD publishing, or document management.

  • Knowledge of ICH guidelines and global health authority regulations.

  • Familiarity with regulatory submission tools and electronic publishing.

  • Strong attention to detail, organizational, and documentation skills.

  • Ability to work collaboratively in a team and follow detailed instructions.

  • Excellent communication skills in English.


Why Join Accenture Life Sciences?

  • Gain experience working with leading global biopharma companies.

  • Opportunity to learn end-to-end regulatory operations and eCTD submissions.

  • Develop expertise in clinical, pharmacovigilance, and regulatory sub-offerings.

  • Exposure to international regulatory standards and global filing processes.

  • Collaborative and inclusive work culture with professional growth opportunities.


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