Regulatory AI and Content Specialist at Roche – Apply
Roche regulatory jobs offer a rare chance to join Roche as a Regulatory AI and Content Specialist in Hyderabad, India. This role offers an opportunity to drive digital transformation in regulatory content, leveraging AI technology in a dynamic environment. Interested candidates are encouraged to apply soon.
About the Company
Roche is a global healthcare company operating in the pharmaceutical and diagnostics sectors. With a commitment to advancing science and ensuring access to healthcare, Roche employs over 100,000 colleagues worldwide. The organization focuses on innovation and collaboration to improve patient outcomes and enhance the quality of life for individuals globally.
Job Details
- Company: Roche
- Location: Hyderabad, Telangāna, India
- Job Id: 202609-123378
Roche regulatory jobs: The Position
- Title: Regulatory AI and Content Specialist
As a Regulatory AI & Content Specialist, the individual will serve as the bridge between Pharma Development Regulatory (PDR), content management, and AI-enabled technology, driving the digital transformation of regulatory content within the PDR organization. This role involves leveraging an understanding of regulatory documents, content structures, and submission requirements to design, standardize, and optimize reusable regulatory content for AI-powered authoring and automation. Among Roche regulatory jobs, this role is particularly focused on connecting regulatory expertise with structured content and AI-enabled workflows.
Key Responsibilities
- Have a strong understanding of regulatory documents across the drug development lifecycle, including clinical, non-clinical, CMC, and CTD-based submissions.
- Apply knowledge of Generative AI, structured content, and regulatory authoring principles to support AI-enabled content creation and document standardization.
- Stay current with evolving regulatory requirements, AI capabilities, and industry best practices.
- Analyze regulatory documents and convert them into standardized templates, reusable content components, and structured content models within the in-house GenAI-powered platform.
- Configure and maintain templates, metadata, and content assets to enable efficient, compliant, and AI-assisted regulatory authoring.
- Support content governance through template lifecycle management, version control, and content quality.
- Serve as a super user for the GenAI-powered platform, providing business support, user enablement, and contributing to continuous improvement initiatives.
- Collaborate with stakeholders across PDR, PD, PT (Pharma Technical), and RDT (Roche Digital Technology) to align regulatory content with business and platform requirements.
Eligibility Criteria
- 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 in leading/supporting clinical or marketing authorization submissions, with a good understanding of the drug development lifecycle, ICH guidelines, CTD/eCTD structure, and regulatory expectations of major health authorities.
- Ability to critically review and interpret regulatory, clinical, and safety documents, and translate them into standardized, structured content for AI-enabled authoring.
- Knowledge of Generative AI, AI-enabled content authoring, and digital technologies, with an interest in applying them to regulatory processes.
- Experience with structured content authoring, document templating, content management, Regulatory Information Management (RIM), or AI-enabled authoring platforms.
- Excellent analytical, written communication, collaboration, and stakeholder management skills, with a continuous learning mindset and attention to detail.
How to Apply
Interested candidates can apply through the following link: CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
For professionals exploring Roche regulatory jobs, this position presents a unique opportunity to contribute to the transformation of regulatory processes through innovative AI solutions. Interested individuals are encouraged to apply before the deadline to be part of a team that values creativity and collaboration in advancing healthcare solutions.
