Regulatory AI & Automation Specialist

By Admin · Regulatory Affairs

HYDERABAD (IN)ONSITEPOSTED: 9/11/2026
PHARMAFull-time
HIRING ORGANIZATIONROCHEPharmaceuticals and Diagnostics
Roche

ROLE OVERVIEW

Drive AI and automation innovation across global regulatory operations by building production-ready solutions for document intelligence, regulatory workflows and compliance tracking.

ROLE DEFINITION & RESPONSIBILITIES

  • •Evaluate incoming AI and automation requests and assess technical feasibility
  • •Build and deploy AI, machine learning and automation solutions using Python, NLP, RPA, low-code/no-code platforms and cloud services
  • •Perform process mining and identify high-impact automation opportunities with regulatory SMEs
  • •Support production maintenance, monitoring, troubleshooting and performance management of deployed AI and automation assets
  • •Maintain solution architecture, source code repositories and testing frameworks
  • •Conduct internal training and support adoption across global regulatory functions
  • •Drive Agile and DevOps execution through PoCs, sprint planning, iterative testing and feedback
  • •Monitor operational metrics and communicate technical insights and improvement recommendations to stakeholders
Reporting Hierarchy: Reports within Roche Services & Solutions and the PD Regulatory Innovation and Sustainment Chapter; Collaborates with global regulatory SMEs, IT, RSS peers and cross-functional stakeholders

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Bachelor's or Master's degree in Computer Science, Data Science, Information Technology, Statistics or related quantitative field
  • 4-6 years of hands-on experience building and deploying software, automation or AI/ML solutions
  • Direct experience in pharmaceutical R&D Regulatory Affairs or clinical development
  • Advanced Python and SQL proficiency
  • Practical NLP, OCR and unstructured document processing experience
  • Experience with REST APIs, Git, unit testing and basic CI/CD

PREFERRED QUALIFICATIONS

  • •Experience with prompt evaluation frameworks or multi-agent orchestration
  • •Experience with LangChain, LlamaIndex, OpenAI or AWS Bedrock APIs
  • •Experience building RAG pipelines
  • •Knowledge of Power Automate or UiPath
  • •AWS or Azure and Docker exposure
  • •Knowledge of ICH guidelines, FDA/EMA submission processes, eCTD and GxP

REQUIRED VERIFIED SKILLS

Python
SQL
Artificial Intelligence
Machine Learning
NLP
OCR
RAG
LLM integration
REST APIs
Git
unit testing
CI/CD
RPA
workflow automation
AWS
Azure
Docker
regulatory affairs
pharmaceutical R&D
GxP

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health insurance, paid leave, employee wellbeing programs and professional development opportunities
Salary is not disclosed in the supplied source. No compensation figures have been inferred.

ORGANIZATION CONTEXT & CULTURE

Roche is a global healthcare company focused on advancing science, medicines and diagnostics. Roche Services & Solutions supports Roche operations globally through end-to-end business services and solutions.

TEAM SIZE: 100,000+ employees globally; Roche Services & Solutions comprises 3,500+ colleagues
INDUSTRY: Pharmaceuticals and Diagnostics
Culture: Roche emphasizes inclusion, personal expression, open dialogue, collaboration, innovation and patient-centric outcomes in a highly regulated and transformative environment.

EXPECTED CAREER ROADMAP

Potential progression into Senior AI/Automation Specialist, Regulatory Technology Lead, AI Product Lead or Regulatory Innovation leadership roles, with opportunities to expand responsibility across global regulatory operations and enterprise digital transformation.

APPLICATION ADVISORY

Emphasize 4-6 years of hands-on AI/automation delivery; demonstrate production Python and SQL projects; highlight NLP, OCR, LLM and RAG implementations; show pharmaceutical regulatory or clinical development exposure; quantify automation, throughput or compliance improvements; mention cloud, API and DevOps experience.

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.