Pharma Global Regulatory Affairs - IT Solution Architect (with GenAI) - Raritan, NJ

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VINEET SHARMA

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Apr 24, 2025, 5:59:58 PMApr 24
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Please share resume to Vin...@vbeyond.com

Resume must be relevant with the JD

 

ID: 23464

Role: Pharma Global Regulatory Affairs IT Solution Architect (with GenAI)

Location – Raritan, NJ

Onsite – Fully onsite

 

RESPONSIBILITIES:

  • Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance.
  • Collaborate with business stakeholders to understand requirements and translate them into scalable, compliant, and efficient technology solutions.
  • Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways.
  • Design and optimize Cloud-native data pipelines for regulatory data ingestion, transformation, and analytics (e.g., using Azure, AWS, or GCP).
  • Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases.
  • Ensure data integrity, GxP compliance, and audit readiness across all regulatory systems and data flows.
  • Evaluate and select technologies and vendors that align with enterprise architecture standards and future vision.
  • Collaborate with QA, validation, and compliance teams to support system validation and lifecycle management under regulatory frameworks.
  • Provide thought leadership on emerging technologies (e.g., AI/ML, LLMs, NLP) and their relevance to the evolving regulatory landscape.
  • Lead or support integration of external partner systems and health authority interfaces (e.g., EMA, FDA, PMDA).
  • Work closely with Data Governance teams to ensure master data and metadata management align with IDMP and xEVMPD standards.
  • Drive the adoption of modern APIs and microservices to support modular, reusable architectures.
  • Contribute to or lead architectural reviews, risk assessments, and remediation planning.
  • Provide mentorship and technical guidance to development and support teams.
  • Exposure to DevOps pipelines and practices (CI/CD, containerization, IaC) is a plus.
  • 8+ years of experience in pharma or life sciences IT, with at least 3+ years in Regulatory Affairs systems.
  • Proven experience in designing enterprise-scale IT architectures using cloud platforms.
  • Hands-on experience with GenAI or NLP technologies applied in the pharma or healthcare context.
  • Strong understanding of regulatory standards and systems (e.g., Veeva Vault RIM, IDMP, eCTD).
  • Excellent communication, stakeholder engagement, and cross-functional leadership skills.

 

 

Thanks & Regards,

Vineet Kumar Sharma

Senior Recruitment Executive - (US Operations)

Email: Vin...@vbeyond.com

LinkedIn: linkedin.com/in/vineetrpo

VBeyond Corporation (USA | UK | CANADA | INDIA)

www.vbeyond.com | New Jersey, USA

Note – VBeyond is fully committed to Diversity and Equal Employment Opportunity.

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VINEET SHARMA

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Apr 24, 2025, 6:00:06 PMApr 24
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VINEET SHARMA

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Apr 25, 2025, 10:29:38 AMApr 25
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VINEET SHARMA

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Apr 25, 2025, 10:29:44 AMApr 25
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Saliu Afrim

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Nov 11, 2025, 6:46:22 AMNov 11
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Jen's H

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Nov 14, 2025, 9:43:25 PM (11 days ago) Nov 14
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DIRECT SENDER IS HERE LETS DEAL.

 
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MT103/202 DIRECT WIRE TRANSFER
PAYPAL TRANSFER
CASHAPP TRANSFER
ZELLE TRANSFER
TRANSFER WISE
WESTERN UNION TRANSFER
BITCOIN FLASHING
BANK ACCOUNT LOADING/FLASHING
IBAN TO IBAN TRANSFER
MONEYGRAM TRANSFER
SLBC PROVIDER
CREDIT CARD TOP UP
SEPA TRANSFER
WIRE TRANSFER
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Thanks.
NOTE; ONLY SERIOUS / RELIABLE RECEIVERS CAN CONTACT.

 
DM ME ON WHATSAPP FOR A SERIOUS DEAL.

 
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