LifeScience Regulatory Services Associate
Company: Accenture
Location: Bengaluru, Karnataka, India
Experience Required: 0–2 years
Job Type: Full-time
Compensation: Not disclosed
Job ID: AIOC-S01592112
Job Summary
Accenture is hiring a LifeScience Regulatory Services Associate to support regulatory operations in global submissions, document QC, and eCTD compliance. This role is ideal for candidates passionate about regulatory affairs, life sciences documentation, and pharmaceutical submissions, with a focus on adhering to ICH guidelines and Health Authority requirements.
Key Responsibilities
Perform bookmarking and hyperlinking for submission documents.
Conduct document quality control (QC) checks for regulatory submissions.
Transform and review source documents as per ICH and Health Authority standards.
Manage and process electronic submissions, including original filings, CMC updates, amendments, annual reports, SPL submissions, and promotional materials.
Coordinate essential documentation for global application filings.
Collaborate with team members and supervisors to ensure regulatory compliance.
Work in rotational shifts as required.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences or related field.
0–2 years of experience in regulatory operations, submissions, or document QC.
Familiarity with ICH guidelines and electronic submissions (eCTD).
Strong attention to detail and ability to manage multiple regulatory documents.
Proficiency in MS Office tools (Word, Excel, PowerPoint).
Good communication and documentation skills.
Perks & Benefits
Opportunity to work with a global leader in regulatory operations.
Comprehensive training on regulatory submissions and eCTD processes.
Access to certifications and skill development programs.
Inclusive and diverse workplace culture.
Employee well-being initiatives covering physical, mental, and financial health.
Company Description
Accenture is a global professional services leader with expertise in digital, cloud, security, and regulatory operations, serving clients in over 120 countries. The Life Sciences R&D vertical supports pharmaceutical and biopharma companies in clinical research, pharmacovigilance, and regulatory submissions, driving innovation and compliance.
Work Mode
On-site – Bengaluru, Karnataka (rotational shifts).
Call to Action
Kickstart your career in regulatory operations with Accenture. Apply now for the LifeScience Regulatory Services Associate role and join a global leader in life sciences.
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