Advertisement
Looking for a Regulatory Operations job in Bangalore with strong exposure to eCTD publishing and Veeva RIM? A leading global healthcare company is hiring for Associate II Regulatory Operations role with 3โ4 years of experience in regulatory publishing, dossier compilation, and global submissions.
This is an excellent opportunity for B.Pharm, M.Pharm, and Life Sciences graduates aiming to build a career in Regulatory Affairs and Publishing with international exposure.
๐ Job Overview
- Role: Associate II โ Regulatory Operations
- Location: Bangalore, India
- Experience: 3โ4 Years
- Qualification: B.Pharm / M.Pharm / Life Sciences
- Job Type: Full-Time
- Last Date to Apply: April 22, 2026
๐ Key Responsibilities
- Prepare, compile, and publish regulatory submission dossiers for US, EU, and RoW markets
- Handle eCTD, NeeS, and paper submissions as per global guidelines
- Manage submission lifecycle activities including sequences and amendments
- Perform quality checks (QC) and document reviews for compliance
- Conduct technical validation using tools like DocuBridge or eValidator
- Coordinate with Regulatory Affairs teams for submission timelines
- Maintain submission metadata, reports, and archives
- Ensure compliance with FDA, EMA, MHRA requirements
- Support process improvements and SOP adherence
๐ Required Qualifications & Experience
- Bachelorโs degree in Pharmacy or Life Sciences
- 3โ4 years of experience in:
- Regulatory publishing
- Dossier preparation & submission
- Global regulatory submissions
- Strong expertise in:
- Veeva RIM Publishing (mandatory)
- eCTD structure and submission standards
- Regulatory validators (Extedo, Lorenz, etc.)
- Experience in document QC and submission quality checks
๐ป Technical Skills Required
- Veeva RIM (Publishing module)
- eCTD / NeeS formats
- Regulatory submission tools & validators
- MS Office (Word, Excel, PowerPoint)
๐ค Soft Skills
- Strong attention to detail
- Ability to manage multiple submissions
- Excellent communication skills
- Team-oriented and quality-focused mindset
โญ Preferred Skills (Bonus)
- Experience with multiple global health authorities
- Knowledge of regulatory intelligence
- Exposure to audits or inspection readiness
๐ฐ Salary (Estimated)
- โน6 LPA โ โน10 LPA (based on experience and industry standards)
๐ Why Apply?
- Work on global regulatory submissions (US/EU markets)
- Gain expertise in Veeva RIM and eCTD publishing
- Strong career growth in Regulatory Affairs domain
- Opportunity to work with cross-functional global teams
๐ฉ How to Apply
Advertisement