Accenture is a leading global professional services company with expertise in digital, cloud, and security. With over 699,000 employees across 120+ countries, Accenture delivers cutting-edge solutions in strategy, consulting, technology, and operations. The Life Sciences R&D division focuses on clinical trials, regulatory services, pharmacovigilance, and patient-centric solutions, helping biopharma companies bring innovative treatments to market.
Detailed Job Description
Job Title: LifeScience Regulatory Services Associate
Location: Bengaluru
Job No: AIOC-S01592118
Experience: 0-2 years
Employment Type: Full-time
Key Responsibilities:
- Perform regulatory operations tasks (bookmarking, hyperlinking) for submission documents following ICH & Health Authority guidelines.
- Review and transform source documents for compliance.
- Conduct Quality Control (QC) checks on submission components.
- Manage electronic submissions (original filings, amendments, CMC, annual reports, SPL submissions).
- Support global regulatory filings by coordinating essential documentation.
- Work on Life Cycle Management (LCM) submissions for pharmaceuticals.
Skills Required:
- Knowledge of regulatory operations in life sciences.
- Familiarity with eCTD submissions, ICH guidelines, FDA/EMA regulations.
- Attention to detail for document QC and compliance checks.
- Basic understanding of pharmacovigilance & clinical research.
Eligibility Criteria
- Education: Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related fields.
- Experience: 0-2 years in regulatory affairs, pharmacovigilance, or clinical research.
- Freshers with strong academic backgrounds may apply.
Benefits & Career Growth
✅ Global Exposure: Work with top biopharma clients.
✅ Skill Development: Training in regulatory compliance & submissions.
✅ Career Progression: Opportunities in regulatory affairs, pharmacovigilance, and clinical operations.
✅ Work-Life Balance: Rotational shifts with structured work hours.
