Website:
nexzenta.com
Job details:
IT Business Analyst – R&D & Regulatory SystemsExperience: 5–8 Years
Employment: Contract
Location: Gurugram, Ahemdabad | Hybrid / Partial U.S. Hours
Function: IT Business Analysis / Pharma R&D & Regulatory
Role Summary
We are looking for an IT Business Analyst with strong Pharmaceutical R&D and Regulatory domain experience to support business teams and IT stakeholders across India and the U.S.
The ideal candidate should be able to understand pharma business processes, translate business needs into IT requirements, user stories, process flows and UAT scenarios, and coordinate system enhancements with IT/application teams and vendors.
MUST HAVE
- 5–8 years of relevant IT Business Analyst experience.
- Strong Pharmaceutical R&D / Regulatory domain knowledge.
- Hands-on understanding of processes such as:
- Clinical Development
- Analytical R&D
- Formulation Development
- CMC
- Regulatory Submissions
- Product Development Lifecycle
- Stability / Method Validation
- Sample Management / Lab Testing
- Experience translating business requirements into BRDs/FRDs, user stories, process flows and functional requirements.
- Strong experience in UAT planning, test scenarios, defect tracking and business sign-off.
- Understanding of RIM, eCTD, EDMS, QMS, LIMS, ELN or related pharma systems.
- Knowledge of GxP and 21 CFR Part 11.
- Strong stakeholder management and communication skills.
- Ability to work with U.S.-based teams and partial U.S. hours, including availability up to 12 PM U.S. Eastern Time when required.
WANT TO HAVE
- Experience with ANDA, NDA, BLA and eCTD submission lifecycle.
- Exposure to tech transfer, regulatory change control and health authority responses.
- Experience in process gap analysis, business process improvement and system enhancement intake/triage.
- Exposure to reporting, dashboards and operational data analysis.
- Experience working with pharma IT application teams, vendors and cross-functional stakeholders.
GOOD TO HAVE
- Experience in Specialty Pharma / Retail Generics.
- Experience supporting validated/GxP applications.
- Familiarity with Clinical Trial Management, Pharmacovigilance, Labeling or Regulatory Intelligence systems.
- Experience working in a global IT/business partnership model.
Key Responsibilities
- Gather and analyze business requirements from R&D and Regulatory teams.
- Convert business needs into clear IT requirements, user stories and process documentation.
- Coordinate enhancements, issues and change requests with IT/application teams.
- Support UAT, testing, defect management and deployment activities.
- Conduct current-state/future-state gap analysis and process mapping.
- Maintain requirements, action trackers, issue logs and UAT documentation.
- Coordinate with India business teams, U.S. IT, vendors and other stakeholders.
Ideal Profile: Pharma-focused IT Business Analyst who combines R&D/Regulatory process knowledge + business analysis + enterprise application understanding, rather than a purely technical BA or generic IT BA.
Click on Apply to know more.
