Roche India – Roche Services & Solutions (RSS) is hiring for two full-time positions in Hyderabad: Regulatory AI and Content Specialist and Delivery Service Manager – RDT Biometrics and Clinical Evidence. The roles are focused on regulatory content and AI-enabled authoring, and delivery management for clinical data systems and technology initiatives.

Job Details

1. Regulatory AI and Content Specialist

Department/Area: Roche Services & Solutions – Product Development Regulatory (PDR)
Location: Hyderabad
Experience: 4–6 years
Job Type: Full Time
Requisition ID: 202609-123378

Role Overview

The Regulatory AI and Content Specialist will connect Pharma Development Regulatory (PDR), regulatory content management, and AI-enabled technology. The role involves standardizing reusable regulatory content, configuring templates and content assets, and supporting AI-enabled regulatory document authoring.

Responsibilities

• Work with regulatory documents across clinical, non-clinical, CMC, and CTD-based submissions.
• Apply Generative AI, structured content, and regulatory authoring principles to support AI-enabled content creation.
• Analyze regulatory documents and convert them into standardized templates, reusable content components, and structured content models.
• Configure and maintain templates, metadata, and content assets within the in-house GenAI-powered platform.
• Support template lifecycle management, version control, and content quality.
• Serve as a super user for the GenAI-powered platform.
• Provide business support and user enablement for the platform.
• Participate in User Acceptance Testing (UAT), business validation, and release readiness activities.
• Collaborate with PDR, PD, PT (Pharma Technical), and RDT (Roche Digital Technology) colleagues.
• Identify opportunities to improve regulatory content development through AI, automation, and low-code/no-code capabilities.
• Support or lead drafting of regulatory documents using AI-enabled authoring capabilities.

Eligibility / Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacology, Regulatory Affairs, or a related discipline.
• 4–6 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Writing, Medical Writing, or a related pharmaceutical role.
• Experience leading or supporting clinical or marketing authorization submissions.
• Understanding of the drug development lifecycle, ICH guidelines, CTD/eCTD structure, and regulatory expectations of major health authorities including FDA, EMA, MHRA, PMDA, or Health Canada.
• Ability to critically review and interpret regulatory, clinical, and safety documents and convert them into standardized, structured content.
• Knowledge of Generative AI, AI-enabled content authoring, and digital technologies.
• Experience with structured content authoring, document templating, content management, Regulatory Information Management (RIM), or AI-enabled authoring platforms.
• Familiarity with low-code/no-code platforms is desirable.
• Experience with digital platform implementation, UAT, or business validation is preferred.

Required Skills

• Regulatory content management
• Regulatory authoring
• CTD/eCTD
• ICH guidelines
• Generative AI
• Structured content
• Content management
• Regulatory Information Management (RIM)
• AI-enabled authoring
• User Acceptance Testing (UAT)
• Analytical and written communication
• Stakeholder management

2. Delivery Service Manager – RDT Biometrics and Clinical Evidence

Area: RDT Biometrics and Clinical Evidence
Location: Hyderabad
Experience: 5–8 years
Job Type: Full Time
Requisition ID: 202607-119629

Role Overview

The Delivery Service Manager leads moderately complex deliveries, manages stakeholders, identifies improvements, and supports strategic implementation. The role can operate across delivery management archetypes including Project Manager, Service Manager, ITSM Process SME, Scrum Master, RTE, or Agile Coach.

The team delivers software systems for Roche clinical trial data acquisition and processing, including electronic data capture, non-CRF systems, and clinical data warehouses.

Responsibilities

• Define, manage, and control the scope of medium to large initiatives or significant workstreams.
• Facilitate scope definition while aligning strategic objectives, stakeholder expectations, and team dependencies.
• Identify, analyze, and mitigate scope-related risks.
• Manage scope changes and promote scope management best practices.
• Lead analysis of moderate to complex delivery problems.
• Conduct root cause analysis and identify stakeholder needs.
• Develop improvement plans and contribute to solution design and validation.
• Manage relationships with diverse stakeholders across functional areas.
• Develop stakeholder communication plans.
• Resolve conflicts and ensure stakeholder alignment.
• Contribute to product and domain goals and strategic objectives.
• Manage moderately complex initiatives and workstreams.
• Manage complex features, services, or projects such as service transitions, product releases, or Agile Release Train (ART) increments.
• Select and adapt delivery methodologies.
• Manage dependencies between activities.
• Translate business needs into delivery strategies.
• Work with Product and team leads to deliver releases and changes in a controlled and agile manner.
• Drive continuous improvements to elevate overall service experience.

Eligibility / Qualifications

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Life Sciences, or a related technical field.
• Professional certifications are an advantage.
• 5–8 years of experience in the pharmaceutical, biotechnology, or regulated healthcare technology industry.
• Proven experience operating in a Delivery Management archetype such as Project Manager, Service Manager, Scrum Master, RTE, or Agile Coach.
• Experience managing medium to large initiatives or significant workstreams.
• Experience managing complex features or projects across functional areas.
• Experience translating requirements into strategic implementation plans and contributing to business planning and forecasting.

Required Skills

• Delivery management
• Project management
• Service management
• Scrum Master / Agile delivery
• Stakeholder management
• Root cause analysis
• Scope management
• Strategic implementation
• Delivery methodologies
• GxP regulated environments
• Computer systems validation
• Analytical skills
• Workshop facilitation
• Conflict resolution
• Coaching and mentoring

Application Details