Accenture is hiring for the position of LifeScience Regulatory Services Associate in Bengaluru, Karnataka. This full-time opportunity is suitable for candidates with a Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) qualification and 1–3 years of experience in life sciences regulatory operations.
The role focuses on regulatory submission document preparation, PDF bookmarking and hyperlinking, document-level quality control, and compliance with applicable regulatory guidelines.
Job Details
| Particulars | Details |
|---|---|
| Company | Accenture |
| Job Title | LifeScience Regulatory Services Associate |
| Job Requisition ID | AIOC-S01672802 |
| Job Location | Bengaluru, BDC9A |
| Job Type | Full-time |
| Experience | 1–3 years |
| Qualification | B.Pharm / M.Pharm |
| Required Skill | Life Sciences Regulatory Operations |
| Work Schedule | Rotational shifts may be required |
Position
LifeScience Regulatory Services Associate – Regulatory Operations
The selected candidate will support regulatory submission operations by reviewing, preparing, correcting, and quality-checking electronic submission documents for compliance with applicable health authority guidelines.
Responsibilities
Key responsibilities include:
- Bookmarking and hyperlinking PDF files in accordance with FDA guidelines and other health authority requirements.
- Correcting and verifying bookmarks and hyperlinks in regulatory submission PDFs.
- Performing document-level reviews and quality control checks on submission documents.
- Conducting initial regulatory reviews of documents intended for publishing.
- Reviewing and transforming source documents into submission-ready formats.
- Ensuring regulatory submission components meet applicable ICH and health authority requirements.
- Coordinating essential documentation and resources required for global regulatory filings.
- Supporting electronic submissions, including original applications and lifecycle management submissions.
- Processing submissions related to CMC, advertising and promotional materials (Ad-promos), amendments, annual reports, and SPL submissions.
Eligibility and Qualifications
Candidates applying for the Accenture Regulatory Services Associate job should meet the following requirements:
- Educational Qualification: Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm).
- Work Experience: 1–3 years.
- Relevant Domain: Life Sciences Regulatory Operations.
- Ability to perform regulatory document review, correction, and quality control activities in accordance with applicable guidelines.
Required Skills
- Life Sciences Regulatory Operations
- Regulatory submission document preparation and review
- PDF bookmarking and hyperlinking
- Document-level quality control
- Regulatory document correction and verification
- Understanding of FDA, EU, Canadian, and other applicable health authority requirements
- Familiarity with ICH guidelines
- Electronic regulatory submissions and lifecycle management documentation
