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Lifescience Regulatory Svs Associate

1-3 years
Not Disclosed
10 Dec. 2, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

LifeScience Regulatory Services Associate

Location: Bengaluru, India
Job Type: Full Time
Experience Required: 0–2 years (1–3 years preferred)
Job ID: AIOC-S01615323

Position Overview

Accenture is hiring a LifeScience Regulatory Services Associate to support its Life Sciences R&D regulatory operations. This entry-level role focuses on electronic submissions, document processing, and operational support across global regulatory filings. The position is ideal for B.Pharm graduates with foundational exposure to eCTD publishing, regulatory documentation, and life sciences regulatory workflows.


Key Responsibilities

  • Perform regulatory operations tasks including bookmarking, hyperlinking, and preparing granular document components for global submissions.

  • Review and transform source documents in alignment with ICH guidelines and regulatory authority requirements.

  • Conduct Quality Control checks for all submission components to ensure accuracy and compliance.

  • Coordinate essential documentation and resources required for global regulatory application filings.

  • Support the processing of electronic submissions such as original applications, lifecycle management submissions, CMC updates, Ad-Promo submissions, amendments, annual reports, SPL submissions, and related records.

  • Manage routine tasks using established procedural guidelines, with detailed instructions for new assignments.

  • Collaborate within a structured team environment, interacting primarily with team members and direct supervisors.

  • Deliver assigned responsibilities as an individual contributor within a defined operational scope.

  • Ability to work in rotational shifts as required.


Required Skills and Competencies

  • Basic understanding of regulatory operations, eCTD publishing, or document publishing workflows.

  • Strong organizational and documentation skills.

  • Ability to follow structured guidelines for regulatory deliverables.

  • Problem-solving skills with the ability to manage routine tasks effectively.

  • Attention to detail and accuracy in document processing.

  • Willingness to learn and adapt quickly to regulatory tools, platforms, and submission processes.


Education & Experience

  • Qualification: Bachelor of Pharmacy

  • Experience:

    • Minimum: 0–2 years in Regulatory Operations

    • Preferred: 1–3 years with exposure to eCTD/document publishing


About Accenture

Accenture is a global professional services firm with deep capabilities in digital, cloud, and security. With more than 699,000 employees across 120+ countries, Accenture delivers end-to-end solutions across Strategy and Consulting, Technology, Operations, and Accenture Song. The Life Sciences R&D vertical supports global pharmaceutical and biotechnology clients with regulatory operations, clinical trial support, pharmacovigilance, and patient services.

Accenture fosters a diverse, inclusive, and innovation-driven culture, providing opportunities for continuous learning and career growth.


Equal Employment Opportunity

Accenture follows a strict non-discrimination policy across all hiring and employment decisions, ensuring equal opportunities for all applicants regardless of age, gender, race, nationality, disability, or any protected status.


Important Notice

Accenture does not charge any fees during the recruitment process. If you receive any request for payment, report it immediately to india.fc.check@accenture.com.