Life Sciences Regulatory Services Associate
Job ID: AIOC-S01615323
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Experience Required: 0–2 years (Freshers with relevant exposure may apply)
Education Required: Bachelor of Pharmacy (B.Pharm)
Functional Area: Regulatory Affairs | Life Sciences Regulatory Operations
Industry: Pharmaceuticals | Life Sciences | Healthcare Consulting
Job Overview
Accenture is hiring a Life Sciences Regulatory Services Associate to support global regulatory operations within its Life Sciences R&D vertical. This role offers early-career professionals an opportunity to work on electronic regulatory submissions, document publishing, and quality control activities aligned with international regulatory standards such as ICH and global health authority requirements.
The position is ideal for pharmacy graduates seeking to build a long-term career in regulatory affairs, eCTD publishing, and life cycle management submissions.
Key Responsibilities
Perform regulatory operations activities including bookmarking and hyperlinking of submission documents in compliance with ICH and global health authority guidelines.
Review, format, and transform source documents for regulatory submissions.
Conduct quality control (QC) checks on submission components to ensure accuracy, completeness, and regulatory compliance.
Support preparation and coordination of essential documentation for global regulatory filings.
Process and manage electronic submissions, including:
Original application filings
Life Cycle Management submissions (CMC, amendments, annual reports)
Advertising and promotional submissions
SPL and other regulatory documentation
Collaborate with internal teams to ensure timely and compliant regulatory deliverables.
Follow defined procedures, guidelines, and workflows to complete routine regulatory tasks efficiently.
Required Skills & Competencies
Basic understanding of Life Sciences Regulatory Operations and submission processes.
Knowledge or exposure to eCTD publishing or document publishing is preferred.
Strong attention to detail and document quality standards.
Ability to follow structured processes and regulatory guidelines.
Good written and verbal communication skills.
Willingness to work in rotational shifts, if required.
Qualifications & Experience
Bachelor of Pharmacy (B.Pharm) is mandatory.
0–2 years of experience in regulatory operations, eCTD publishing, document publishing, or related areas.
Fresh graduates with academic or internship exposure to regulatory affairs may also be considered.
About Accenture
Accenture is a global professional services company with strong capabilities in digital, cloud, security, and intelligent operations, serving clients across more than 120 countries. Within its Life Sciences R&D practice, Accenture partners with leading biopharmaceutical organizations to support clinical research, pharmacovigilance, regulatory services, and patient-centric solutions, enabling faster and compliant access to medicines worldwide.
Why Join Accenture
Entry-level opportunity in global regulatory affairs and life sciences operations
Exposure to international regulatory standards and submissions
Structured learning, training, and career development pathways
Collaborative, technology-driven work environment
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