Roche is hiring for the position of Regulatory AI and Content Specialist in Hyderabad, Telangana. This is a full-time opportunity with Roche India – Roche Services & Solutions (RSS), within the area supporting Product Development Regulatory activities.
The role combines Regulatory Affairs, regulatory content management, Generative AI, structured content and digital technology. The selected professional will help transform regulatory documents into reusable, standardized content that can support AI-assisted authoring and compliant document generation.
Candidates with a Bachelor’s or Master’s degree in Life Sciences, Pharmacology, Regulatory Affairs or a related field and 4–6 years of relevant pharmaceutical experience may be eligible. The application deadline is October 7, 2026.
Roche Regulatory AI and Content Specialist – Job Highlights
| Particular | Details |
|---|---|
| Company | Roche |
| Job Title | Regulatory AI and Content Specialist |
| Department / Function | Roche Services & Solutions / Product Development Regulatory |
| Location | Hyderabad, Telangana |
| Job Type | Full Time |
| Experience | 4–6 Years |
| Qualification | Bachelor’s or Master’s degree in Life Sciences, Pharmacology, Regulatory Affairs or related discipline |
| Key Areas | Regulatory Affairs, Regulatory Content, Generative AI, Content Management, AI-enabled Authoring |
| Requisition ID | 202609-123378 |
| Application Deadline | October 7, 2026 |
| Salary / CTC | Not specified |
About Roche
Roche is a global healthcare company focused on advancing science and developing solutions that help improve healthcare outcomes. Its activities span pharmaceuticals and diagnostics, with a strong emphasis on research, innovation and technology.
Roche Services & Solutions supports Roche’s global operations through business services and solutions. The Hyderabad organization is part of Roche’s international network supporting business and technology-driven capabilities.
Job Description
The Regulatory AI and Content Specialist will work at the intersection of regulatory content, pharmaceutical development and AI-enabled technology.
The role involves understanding regulatory documents and submission requirements, converting information into structured and reusable content, and helping configure templates and content assets within Roche’s in-house Generative AI-powered platform.
The specialist will also work with regulatory document authors and other stakeholders to support the creation of high-quality, consistent and submission-ready documents using AI-assisted authoring capabilities.
Regulatory AI and Content Specialist – Role Overview
This position is designed for professionals who understand both pharmaceutical regulatory documentation and emerging digital technologies.
The successful candidate will help establish structured regulatory content, manage templates and content assets, support platform users, participate in testing activities and identify opportunities where AI and automation can improve regulatory content development.
Educational Qualification
Candidates should have a:
- Bachelor’s degree in Life Sciences, Pharmacology, Regulatory Affairs or a related discipline; or
- Master’s degree in one of these or a closely related field.
Experience Requirements
Candidates should have approximately 4–6 years of experience in one or more of the following areas:
- Regulatory Affairs
- Regulatory Operations
- Regulatory Writing
- Medical Writing
- Related pharmaceutical functions
Relevant experience supporting or leading clinical or marketing authorization submissions is also expected.
Regulatory Knowledge
Candidates should have a good understanding of:
- Drug development lifecycle
- Regulatory submissions
- ICH guidelines
- CTD structure
- eCTD structure
- Regulatory expectations of major health authorities
- Clinical documentation
- Non-clinical documentation
- CMC documentation
- Regulatory content requirements
Knowledge of regulatory authorities such as the FDA, EMA, MHRA, PMDA or Health Canada is relevant to the role.
Generative AI and Digital Technology Skills
The position requires an interest in applying emerging technology to regulatory processes. Relevant knowledge includes:
- Generative AI
- AI-assisted content authoring
- Structured content
- Digital content technologies
- Content management
- Document templating
- Regulatory Information Management (RIM)
- AI-enabled authoring platforms
- Low-code/no-code technologies
Experience with structured content authoring or regulatory technology platforms would be beneficial.
Key Responsibilities
Regulatory Content and AI
The specialist will:
- Apply knowledge of regulatory documentation across different stages of pharmaceutical development.
- Work with clinical, non-clinical, CMC and CTD-based regulatory content.
- Apply regulatory authoring principles to AI-supported content creation.
- Support standardization of regulatory documents and content.
- Monitor developments in regulatory requirements, AI capabilities and industry practices.
Regulatory Content Management
Responsibilities will include:
- Reviewing regulatory documents and identifying reusable content.
- Converting documents into standardized templates and structured content components.
- Configure and maintain templates, metadata and content assets within the organization’s AI-enabled platform.
- Support content governance and quality management.
- Manage template lifecycle and version control activities.
- Help maintain consistency and quality across regulatory content.
AI Platform Enablement
The role will also involve:
- Acting as a knowledgeable user of Roche’s GenAI-powered regulatory authoring platform.
- Supporting users with platform-related business requirements.
- Helping improve adoption and operational use of the platform.
- Supporting continuous improvement initiatives.
- Participating in User Acceptance Testing (UAT).
- Supporting business validation and release-readiness activities.
- Working with stakeholders to ensure new platform capabilities meet business requirements.
Cross-Functional Collaboration
The specialist will collaborate with teams and stakeholders across:
- Product Development Regulatory (PDR)
- Product Development (PD)
- Pharma Technical (PT)
- Roche Digital Technology (RDT)
- Regulatory document authors
- Other relevant business stakeholders
The position will also involve identifying opportunities to improve regulatory content development through AI, automation and low-code/no-code solutions.
Preferred Experience
The following experience would be advantageous:
- Structured content authoring
- Regulatory content management
- Document templating
- Regulatory Information Management systems
- AI-enabled authoring platforms
- Low-code/no-code platforms
- Digital platform implementation
- User Acceptance Testing
- Business validation activities
Experience supporting technology implementation within regulatory or pharmaceutical environments can be particularly relevant.
Required Skills
Candidates should demonstrate:
- Strong analytical ability
- Excellent written communication
- Regulatory content interpretation skills
- Stakeholder management
- Cross-functional collaboration
- Attention to detail
- Ability to critically review regulatory and scientific documents
- Ability to structure complex content
- Understanding of pharmaceutical regulatory processes
- Interest in emerging AI technologies
- Continuous learning mindset
Work Location and Job Type
- Location: Hyderabad, Telangana
- Job Type: Full Time
- Organization: Roche India – Roche Services & Solutions
- Function: Product Development Regulatory
The vacancy information provided does not specify a remote or hybrid work arrangement.
Salary / CTC
Roche has not specified the salary or CTC for the Regulatory AI and Content Specialist position in the available vacancy information.
Candidates should refer to the official Roche recruitment communication for compensation-related details.
Selection Process
The detailed selection process has not been specified in the vacancy information provided.
Candidates may be assessed based on their regulatory experience, knowledge of pharmaceutical submissions, content management capabilities, AI/digital technology understanding and ability to work with cross-functional stakeholders.
How to Apply for Roche Regulatory AI and Content Specialist
Interested and eligible candidates should review the vacancy details and submit their application through Roche’s official recruitment platform before the stated deadline.
Application Deadline
October 7, 2026
Candidates are advised to apply before the closing date because the vacancy is currently listed with limited time remaining.
Important Details Before Applying
- The position is based in Hyderabad.
- This is a full-time opportunity.
- The required experience is 4–6 years in relevant regulatory, medical writing or pharmaceutical roles.
- A Bachelor’s or Master’s degree in a relevant life science, pharmacology or regulatory discipline is required.
- Knowledge of CTD/eCTD and ICH guidelines is important.
- Experience with clinical or marketing authorization submissions is relevant.
- Generative AI and AI-enabled content authoring knowledge is expected.
- Experience with structured content, RIM, document templates or AI-enabled authoring platforms is advantageous.
- UAT, business validation or digital platform implementation experience is preferred.
- Salary/CTC has not been disclosed.
- The application deadline is October 7, 2026.
- Candidates should verify the latest vacancy status on the official Roche careers platform before applying.
Frequently Asked Questions
1. What is the job title at Roche?
The position is Regulatory AI and Content Specialist.
2. Where is the Roche Regulatory AI and Content Specialist job located?
The position is located in Hyderabad, Telangana, India.
3. What is the required experience?
The vacancy indicates 4–6 years of relevant experience in Regulatory Affairs, Regulatory Operations, Regulatory Writing, Medical Writing or a related pharmaceutical function.
4. What educational qualification is required?
Candidates should have a Bachelor’s or Master’s degree in Life Sciences, Pharmacology, Regulatory Affairs or a related discipline.
5. What regulatory knowledge is required?
Candidates should understand the drug development lifecycle, ICH guidelines, CTD/eCTD structures and regulatory expectations of major health authorities.
6. Is Generative AI experience required?
Knowledge of Generative AI, AI-enabled content authoring and digital technologies is relevant to the position. The role specifically focuses on applying these technologies to regulatory processes.
7. Is experience with RIM or content management useful?
Yes. Experience with structured content authoring, document templating, content management or Regulatory Information Management is desirable.
8. Is UAT experience preferred?
Yes. Experience supporting digital platform implementation, User Acceptance Testing or business validation activities is preferred.
9. What is the job type?
The position is listed as Full Time.
10. What is the Roche requisition ID?
The requisition ID is 202609-123378.
11. What is the application deadline?
The listed deadline is October 7, 2026.
12. What is the salary for this Roche job?
The salary or CTC has not been specified in the available vacancy information.
Important Note
Recruitment requirements, vacancy status, application deadlines, work arrangements and other hiring conditions may change. Candidates should verify all details on the official Roche careers platform before applying and should rely on the employer’s official recruitment communication for the latest information.