Roche is inviting applications for the position of Regulatory AI and Content Specialist at Roche Services & Solutions in Hyderabad, Telangana. Candidates with a Bachelor’s or Master’s degree in Life Sciences, Pharmacology, Regulatory Affairs, or a related discipline are eligible to apply. Applicants should have 4–6 years of relevant pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations, Regulatory Writing, Medical Writing, or related roles. The position focuses on regulatory content management, Generative AI-enabled authoring, and digital transformation of regulatory documentation.
Roche Regulatory AI and Content Specialist Recruitment
Company Overview
Roche is a global healthcare company working across pharmaceuticals and diagnostics to advance medical science and improve patient care. Its work focuses on developing healthcare solutions that help address medical needs worldwide.
Roche Services & Solutions (RSS) supports the organization through end-to-end business services, helping teams operate efficiently and focus on patient-centric activities. With a global network that includes Hyderabad and Chennai in India, RSS works across regions to deliver scalable business solutions.
Within Roche Product Development, Product Development Regulatory (PDR) supports evolving regulatory requirements and global drug development priorities. The team uses automation, AI-enabled capabilities, and emerging technologies to improve regulatory processes and content development.
Job Details
- Company: Roche India – Roche Services & Solutions
- Designation: Regulatory AI and Content Specialist
- Department: Business Services & Support
- Job Category: Business Services
- Location: Hyderabad, Telangana, India
- Experience: 4–6 years
- Employment Type: Full-time, Regular/Permanent
- Job ID: 202609-123378
- Application Deadline: October 25, 2026, at 11:59 p.m. local time, based on the employer’s stated October 26 posting end date and its closing rule.
Job Role & Responsibilities
The Regulatory AI and Content Specialist will connect regulatory affairs expertise with content management and AI-enabled technology. The role involves preparing standardized regulatory content, maintaining reusable templates, supporting AI-assisted document authoring, and helping ensure regulatory documents are accurate, consistent, and ready for submission.
Regulatory Content and AI Expertise
- Apply knowledge of regulatory documents across the drug development lifecycle, including clinical, non-clinical, Chemistry, Manufacturing and Controls (CMC), and Common Technical Document (CTD)-based submissions.
- Use Generative AI, structured content, and regulatory authoring principles to support content creation and document standardization.
- Keep up with changing regulatory requirements, AI capabilities, and industry best practices.
- Review regulatory, clinical, and safety documentation to support the development of structured content for AI-enabled authoring.
Regulatory Content Management and Platform Administration
- 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 Roche’s in-house Generative AI-powered platform.
- Support compliant and efficient AI-assisted regulatory document authoring.
- Maintain content governance through template lifecycle management, version control, and content quality processes.
Platform Enablement and Collaboration
- Act as a super user for the GenAI-powered platform, providing business support and helping users adopt its capabilities.
- Contribute to continuous improvement initiatives that enhance platform adoption and operational efficiency.
- Participate in User Acceptance Testing (UAT), business validation, and release-readiness activities for new platform features.
- Collaborate with colleagues across Product Development Regulatory (PDR), Product Development (PD), Pharma Technical (PT), and Roche Digital Technology (RDT).
- Identify opportunities to improve regulatory content development through AI, automation, and low-code/no-code technologies.
AI-Enabled Regulatory Document Authoring
- Work alongside regulatory document authors to support or lead the drafting of regulatory documents using AI-enabled authoring tools.
- Assess whether AI-generated content is usable, accurate, consistent, and suitable for regulatory submissions.
- Help align content structures and templates with regulatory requirements and business needs.
Eligibility & Qualifications
Candidates should meet the following educational, professional, and technical requirements.
Educational Qualifications
- Bachelor’s degree in Life Sciences, Pharmacology, Regulatory Affairs, or a related discipline.
- Master’s degree in Life Sciences, Pharmacology, Regulatory Affairs, or a related discipline.
Experience Requirements
- 4–6 years of relevant experience in Regulatory Affairs, Regulatory Operations, Regulatory Writing, Medical Writing, or a related pharmaceutical role.
- Experience leading or supporting clinical submissions or marketing authorization submissions.
- Understanding of the drug development lifecycle, ICH guidelines, CTD/eCTD structure, and regulatory expectations of major health authorities.
Technical Knowledge and Required Skills
- Ability to critically review and interpret regulatory, clinical, and safety documents.
- Knowledge of Generative AI, AI-enabled content authoring, and digital technologies.
- Ability to convert regulatory information into standardized, structured content for AI-assisted authoring.
- Strong analytical skills and attention to detail.
- Excellent written communication and collaboration skills.
- Effective stakeholder management and a continuous learning mindset.
Preferred Experience
The following experience would be beneficial:
- Structured content authoring and document templating.
- Content management and Regulatory Information Management (RIM) systems.
- AI-enabled regulatory authoring platforms.
- Low-code/no-code platforms.
- Digital platform implementation, UAT, and business validation activities.
Location & Salary
Job location: Hyderabad, Telangana, India.
The position is listed as full-time and regular/permanent under Roche Services & Solutions.
How to Apply
Interested and eligible candidates can apply through Roche’s official careers website.
- Open the official Roche job listing using the link below.
- Review the job description and eligibility requirements carefully.
- Complete the online application with accurate educational and professional details.
- Upload your updated résumé and any information requested in the application form.
- Submit the application and monitor your email for further communication from Roche.
Official Apply Link: Regulatory AI and Content Specialist – Roche Careers
Important Dates
- Job posted: October 21, 2026
- Posting end date: October 26, 2026
- Application closing time: 11:59 p.m. on the previous day, according to the employer’s stated closing policy and the job location’s time zone.
Candidates should apply promptly and verify the closing details on the official careers page.
Documents Required
Keep the following documents ready for the online application, as applicable:
- Updated résumé or CV.
- Educational qualification details and certificates.
- Employment history and relevant work experience details.
- Information about regulatory submissions, content management, or AI-enabled authoring experience.
- Professional contact details.
Follow the official application portal for the final list of required documents.
Frequently Asked Questions
1. What is the qualification required for the Roche Regulatory AI and Content Specialist role?
Candidates need a Bachelor’s or Master’s degree in Life Sciences, Pharmacology, Regulatory Affairs, or a related discipline.
2. How much experience is required?
The advertised requirement is 4–6 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Writing, Medical Writing, or a related pharmaceutical role.
3. Can freshers apply for this position?
This vacancy is intended for experienced professionals. Freshers would not meet the stated 4–6 years of relevant experience requirement.
4. What is the job location?
The position is based in Hyderabad, Telangana, India, under Roche Services & Solutions.
5. What is the salary for this vacancy?
The salary has not been published in the supplied job details. Applicants can check the official recruitment page or discuss compensation during the hiring process.
Job Summary Table
| Category | Details |
|---|---|
| Company | Roche India – Roche Services & Solutions |
| Vacancies | Regulatory AI and Content Specialist |
| Required Education | Bachelor’s or Master’s degree in Life Sciences, Pharmacology, Regulatory Affairs, or a related discipline |
| Experience | 4–6 years in Regulatory Affairs, Regulatory Operations, Regulatory Writing, Medical Writing, or a related pharmaceutical role |
| Location | Hyderabad, Telangana, India |