Hiring For Regulatory Affairs SME I Product Analyst | Pharma Domain
Sarjen Systems · Ahmedabad · onsite · Posted 28d ago
₹4.0L - ₹8.0L PA3–7 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- eCTD Submission Process
- Regulatory Dossier Management
- Pharma Software Product Analysis
- Customer requirement analysis
- Product demonstrations
- Functional documentation
- Regulatory process consulting
- Regulatory Affairs
- Regulatory variations, renewals, and lifecycle submissions
- Act as Regulatory Affairs domain expert for software product development.
- GPA & Term Plan
- Flexible Time
- Regulatory Dossier Management
- Pharma Software Product Analysis
- Customer requirement analysis
- Product demonstrations
- Functional documentation
- Regulatory process consulting
- Regulatory Affairs
Required Candidate profile
- SPL (Structured Product Labeling) preparation and management- Regulatory variations, renewals, and lifecycle submissions
- Act as Regulatory Affairs domain expert for software product development.
Perks and benefits
- 5 Days week- GPA & Term Plan
- Flexible Time
Sourced from naukri
Skills
DossierMHRAFDAEMAregulatoryRegulatory AffairsSubmissionEctdregulatory submissionsDossier PreparationUSFDARegulatory GuidelinesDossier CompilationActdICHRACTDRowRegulatory ComplianceProduct ManagementFormulationDrug Regulatory Affairs
About Sarjen Systems

Sarjen Systems
IT Services & Consulting
75
employees
1998
28 years old
Ahmedabad, Gujarat
India
₹5.5L PA avg
Avg at Sarjen Systems
₹4L – ₹8L PA
This role
About
Sarjen provides business and GxP compliant software solutions, services across several industry domains including Pharmaceutical, Healthcare, etc.
Industries
IT Services & Consulting
Employee ratings
10 reviews
3.7/ 5
Culture
2.8
Career growth
2.4
Work-life
3.5
Employees rate it well for
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