PHARMAFull-time
Regulatory AI & Automation Specialist
By Admin · Regulatory Affairs
HYDERABAD (IN)ONSITEPOSTED: 9/17/2026
PHARMAFull-time
HIRING ORGANIZATIONROCHEPharmaceuticals and Diagnostics
ROLE OVERVIEW
Drive hands-on AI, machine learning, document intelligence, and workflow automation for global regulatory operations, improving regulatory document processing, submission dossier management, compliance tracking, and operational efficiency.
ROLE DEFINITION & RESPONSIBILITIES
- •Evaluate incoming AI and automation requests with regulatory stakeholders and assess technical feasibility
- •Build and deploy AI, machine learning, RPA, low-code/no-code, Python, NLP, and AWS-based solutions for regulatory workflows
- •Conduct process mining and opportunity mapping with regulatory SMEs
- •Support maintenance, performance monitoring, troubleshooting, and preventive maintenance of deployed AI and automation assets
- •Maintain solution architecture, source-code repositories, testing frameworks, and technical documentation
- •Conduct internal training to drive adoption across regulatory functions
- •Drive Agile and DevOps execution through sprint planning, proof-of-concept development, testing, and feedback cycles
- •Monitor operational metrics and communicate technical insights and improvement recommendations to leadership
Reporting Hierarchy: Reports within Roche Services & Solutions' PD Regulatory Innovation and Sustainment Chapter; Works in a matrix environment with chapter leads, global regulatory teams, IT, RSS peers, and regulatory SMEs
* 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 software engineering, data analytics, AI/ML, or automation development experience
- Direct experience in pharmaceutical R&D regulatory affairs or clinical development
- Advanced Python and SQL skills
- Practical NLP, OCR, and unstructured document-processing experience
- Experience with LLM application development and RAG pipelines
- Experience with REST APIs, Git, unit testing, and basic CI/CD
- Experience with workflow automation using Python, Power Automate, UiPath, or enterprise schedulers
- Basic AWS or Azure and Docker exposure
PREFERRED QUALIFICATIONS
- •Prompt evaluation or multi-agent orchestration experience
- •Experience with LangChain, LlamaIndex, OpenAI APIs, or AWS Bedrock
- •Advanced prompt architecture and validation
- •Knowledge of ICH guidelines, FDA/EMA submission processes, eCTD, GxP, clinical-trial documentation, and emerging AI/ML regulatory guidance
REQUIRED VERIFIED SKILLS
Python
SQL
AI/ML
machine learning
NLP
OCR
Tesseract
AWS Textract
Azure AI Document Intelligence
document parsing
PDF
XML
JSON
Word
LLM integration
RAG
REST APIs
Git
unit testing
CI/CD
RPA
Power Automate
UiPath
AWS
Azure
Docker
regulatory affairs
pharmaceutical R&D
Agile
DevOps
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Benefits are not specifically detailed in the supplied posting; Roche describes a global, inclusive workplace and opportunities for professional growth
No salary or bonus/equity figures are disclosed in the supplied posting. Roche states that compensation and benefits are determined according to applicable role and location factors.
ORGANIZATION CONTEXT & CULTURE
Roche is a global healthcare company operating across pharmaceuticals and diagnostics. Roche Services & Solutions supports global business operations through connected service locations, including Hyderabad and Chennai in India.
TEAM SIZE: 100,000+ employees globally
INDUSTRY: Pharmaceuticals and Diagnostics
Culture: Roche emphasizes inclusion, personal expression, open dialogue, collaboration, innovation, scientific advancement, and patient-centric healthcare outcomes.
EXPECTED CAREER ROADMAP
Potential progression includes Senior AI/Automation Specialist, Regulatory Digital Transformation Lead, AI/ML Solution Architect, Regulatory Technology Lead, or broader digital innovation and regulatory technology leadership roles.
APPLICATION ADVISORY
Highlight the combination of AI/automation engineering and pharmaceutical regulatory experience; demonstrate production deployments rather than only prototypes; showcase Python, SQL, NLP, OCR, LLM, RAG, API, cloud, and automation projects; provide measurable outcomes such as processing-time reduction or compliance improvements; emphasize regulatory document expertise and experience working with global SMEs.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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