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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

LifeScience Regulatory Services Associate

Location: Bengaluru, India
Job Type: Full-Time
Experience Required: 0–2 years (Freshers with relevant skills may also apply)

About the Role

The LifeScience Regulatory Services Associate will support global regulatory operations within the Life Sciences R&D domain. This role involves handling regulatory documentation, ensuring compliance with international guidelines, and contributing to high-quality electronic submissions. The position is ideal for professionals beginning their career in regulatory affairs, document publishing, or eCTD submissions.

Key Responsibilities

  • Execute regulatory operations tasks, including bookmarking and hyperlinking for submission documents in alignment with ICH guidelines and Health Authority requirements.

  • Review, transform, and prepare source documents for global regulatory submissions.

  • Perform document quality control (QC) checks for all components of regulatory submissions.

  • Coordinate essential documentation and resources for filing global applications.

  • Process electronic submissions such as:

    • Original application filings

    • Life cycle management submissions (CMC, amendments, annual reports)

    • Advertising and promotional submissions

    • Structured Product Labeling (SPL) submissions

  • Work as an individual contributor within a defined scope while collaborating closely with team members and supervisors.

  • Operate according to detailed instructions for daily tasks and new assignments.

  • Be available for rotational shift work, based on project requirements.

Skills & Requirements

  • Qualification: Bachelor of Pharmacy (B.Pharm).

  • Experience: 0–2 years (candidates with 1–3 years of experience in eCTD publishing, document publishing, or regulatory operations preferred).

  • Strong understanding of ICH guidelines and regulatory documentation processes.

  • Ability to manage routine tasks with attention to accuracy and compliance.

  • Good communication and teamwork skills; ability to follow established guidelines.

About the Company

Accenture is a leading global professional services organization offering capabilities in digital, cloud, and security. With expertise across more than 40 industries, the company delivers strategy and consulting, technology solutions, operations services, and digital transformation initiatives. Its global workforce of over 699,000 professionals serves clients in more than 120 countries, driving innovation and operational excellence across the life sciences ecosystem.