Life Sciences Regulatory Services Analyst
Location: Bengaluru, India
Employment Type: Full-Time
Industry: Life Sciences | Regulatory Affairs | Regulatory Operations
Experience Required: 3–5 Years
Job ID: AIOC-S01620286
Hiring Organization: Accenture
Role Overview
Accenture is hiring a Life Sciences Regulatory Services Analyst to support global Regulatory Operations within its Life Sciences R&D vertical. This role focuses on managing regulatory submissions, lifecycle maintenance activities, and compliance documentation across global health authority requirements. The position is ideal for professionals with hands-on experience in electronic submissions, regulatory documentation, and lifecycle management within pharmaceutical or biotechnology environments.
Key Responsibilities
Regulatory Operations & Submissions
Coordinate and manage documentation required for global regulatory submissions
Support original application filings and lifecycle management submissions, including CMC, amendments, annual reports, SPL, and promotional materials
Process and manage electronic submissions in compliance with global regulatory standards
Compliance & Documentation
Assist in ensuring regulatory compliance with applicable laws, guidelines, and internal SOPs
Maintain accurate regulatory records and submission trackers
Support audits and compliance reviews as required
Cross-Functional Collaboration
Work closely with internal regulatory, clinical, pharmacovigilance, and quality teams
Communicate effectively with peers and supervisors to ensure timely delivery of regulatory activities
Operational Execution
Analyze and resolve low to medium complexity regulatory operations issues
Execute assigned tasks with moderate supervision while adhering to defined processes
Contribute as an individual contributor within a focused regulatory operations team
Support productivity and delivery commitments as per project requirements
Required Qualifications & Experience
Bachelor of Pharmacy (B.Pharm) mandatory
3–5 years of experience in Life Sciences Regulatory Operations or Regulatory Services
Hands-on experience with global regulatory submissions and electronic publishing processes
Working knowledge of regulatory lifecycle management (LCM) activities
Preferred Skills & Competencies
Understanding of global regulatory frameworks and submission requirements
Experience with eCTD, SPL, CMC, amendments, and annual report submissions
Strong attention to detail and documentation accuracy
Ability to work in a structured, process-driven environment
Effective written and verbal communication skills
Willingness to work in rotational shifts, if required
Why Join Accenture
Work with a global leader in Life Sciences Regulatory and R&D Services
Exposure to large-scale global regulatory programs across pharma and biotech clients
Opportunity to develop regulatory expertise across clinical, pharmacovigilance, and compliance domains
Structured career growth, learning, and upskilling opportunities
Equal Opportunity Statement
Accenture is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, gender, race, religion, disability, or any other protected status.
Apply via ThePharmaDaily.com
Explore verified global opportunities in Regulatory Affairs, Regulatory Operations, Life Sciences Compliance, and Pharma R&D.
Apply now to advance your regulatory career with Accenture in Bengaluru.
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