Life Sciences Regulatory Services Associate – Regulatory Operations (eCTD Publishing)
Location: Bengaluru, India
Company: Accenture
Job Type: Full-Time
Job ID: AIOC-S01615323
Experience Required: 0–2 years (Freshers with relevant exposure may be considered; 1–3 years preferred)
Educational Qualification: Bachelor of Pharmacy (B.Pharm) or equivalent life sciences degree
Overview
Accenture is hiring Life Sciences Regulatory Services Associates to support regulatory operations within its global Life Sciences R&D division. This role is ideal for early-career pharma professionals seeking hands-on experience in regulatory submissions, eCTD publishing, and global compliance processes. You will contribute to enabling leading biopharma companies to bring innovative therapies to market by ensuring high-quality regulatory documentation and submission readiness.
Key Responsibilities
The role involves performing regulatory operations activities including bookmarking and hyperlinking of submission documents in compliance with ICH guidelines and global health authority requirements. You will review, transform, and quality-check source documents, ensuring accuracy and consistency across all submission components.
You will support the preparation and management of electronic submissions such as initial filings, lifecycle management submissions (including CMC, amendments, annual reports, SPL submissions, and promotional materials), while coordinating documentation required for global regulatory filings. The position also requires working with document publishing tools and maintaining high standards of document quality control (QC).
Core Functional Exposure
Candidates will gain exposure across regulatory operations, clinical research support, pharmacovigilance processes, and global submission management. The role plays a key part in aligning scientific documentation with regulatory compliance to support successful product approvals.
Required Skills and Competencies
Applicants should have a foundational understanding of regulatory publishing or eCTD processes. Strong attention to detail, basic knowledge of ICH guidelines, and familiarity with document management systems are essential. Candidates should demonstrate the ability to follow structured processes, solve routine problems, and work effectively within a team environment.
Good communication skills, adaptability to rotational shifts, and the ability to manage assigned tasks with accuracy and efficiency are critical for success in this role.
Work Environment and Growth Opportunities
This position offers the opportunity to work within Accenture’s global delivery network, gaining exposure to international regulatory frameworks and advanced technologies in regulatory operations. Employees benefit from structured training, career development programs, and the opportunity to work with leading pharmaceutical and biotechnology clients worldwide.
Role Expectations
You will function as an individual contributor within a team, working under defined guidelines with moderate supervision. The role requires adherence to timelines, quality standards, and regulatory compliance while contributing to team deliverables.
This is a strong entry-level opportunity for pharmacy graduates looking to build a career in regulatory affairs, eCTD publishing, and global life sciences operations.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Kyiv |Lima Region :
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