LifeScience Regulatory Svs Analyst
About the Role
Roles & Responsibilities
• Support regulatory services activities aligned with Life Sciences R&D operations
• Coordinate documentation and resources required for global regulatory submissions
• Manage and process electronic submissions, including original applications and lifecycle management submissions
• Handle submissions related to CMC, advertising and promotional materials, amendments, annual reports, and SPL submissions
• Prepare, review, and maintain regulatory documentation in compliance with applicable laws and regulations
• Assist in regulatory reporting and submissions to health authorities
• Stay updated with changing regulatory guidelines and support compliance audits
• Perform analysis and resolution of low to medium complexity regulatory problems
• Interact primarily with internal Accenture peers and update supervisors on work progress
• Follow detailed instructions for new assignments and moderate guidance for daily tasks
• Ensure decisions made are accurate and maintain quality standards, impacting own work and team deliverables
• Work as an individual contributor within a team-focused environment
• Be flexible to work in rotational shifts as required
Qualification
• Bachelor of Pharmacy (B.Pharm)
Experience
• 3 to 5 years of experience in Life Sciences Regulatory Operations or Regulatory Services
• Hands-on exposure to global regulatory submissions and electronic publishing processes
Skills
• Strong understanding of life sciences regulatory requirements and submission processes
• Ability to work effectively in a team-oriented environment
• Adaptable and flexible to changing project needs
• High commitment to quality and compliance
• Good analytical and problem-solving skills
• Basic understanding of regulatory lifecycle management and compliance audits
About the Company
Accenture is a global professional services company with expertise in digital, cloud, and security. With over 784,000 professionals across 120+ countries, Accenture delivers strategy, consulting, technology, and operations services to help organizations drive innovation, improve outcomes, and create sustainable value across industries, including life sciences and healthcare.
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