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Location: Remote
Pay Rate: $60/hr Contract
Client: Johnson & Johnson
Duration: 1+ year Contract
Years of Experience: 7-10 years
Visa: USC, GC, H4-EAD, GC-EAD, TN
Interview: 2 Rounds Virtual
Anticipated Start Date: Immediately
Job Summary:
We are seeking a Business Analyst or Process Excellence Consultant with deep domain expertise in Regulatory CMC (Chemistry, Manufacturing, and Controls) to support our large pharmaceutical client’s digital transformation initiatives. You’ll bring first-hand experience working in Regulatory CMC functions and apply that expertise to business process optimization, system design, and stakeholder alignment. Prior experience with a pharmaceutical company is a must.
Responsibilities:
Serve as the Regulatory CMC subject matter expert on cross-functional workstreams.
Map current-state CMC regulatory processes (e.g., Module 3 authoring, variation management, manufacturing site updates) and identify improvement opportunities.
Collaborate with stakeholders and technical teams to define future-state workflows, supporting structured content and data models within Veeva Vault RIM.
Gather and document business requirements, use cases, and system dependencies.
Partner with regulatory and technical leads to ensure platform functionality supports CMC regulatory obligations globally.
Facilitate workshops, process walkthroughs, and feedback loops with CMC SMEs.
Contribute to system validation efforts by supporting test case development and execution for CMC scenarios.
Qualifications:
5–10 years of experience in Regulatory CMC, including submissions, post-approval changes, or global variation management.
Prior experience in business analysis, process optimization, or transformation programs.
Familiarity with Veeva Vault RIM or similar platforms preferred.
Strong documentation, facilitation, and stakeholder engagement skills.
Experience with global Health Authority expectations and CMC data requirements.
To apply for this job email your details to aditya.jain@nytpcorp.com