PHARMAFull time
Regulatory AI & Content Specialist
HYDERABAD (IN)ONSITEPOSTED: 9/30/2026
PHARMAFull time
HIRING ORGANIZATIONROCHEPharmaceuticals and Diagnostics
ROLE OVERVIEW
This Regulatory AI & Content Specialist role at Roche India sits within Product Development Regulatory and Roche Services & Solutions, a strategic hub driving digital transformation of regulatory content. The position bridges regulatory affairs, structured content management, and generative AI, helping standardize reusable content for AI-powered authoring and automation. It is critical to Roche’s global submissions because high-quality, compliant regulatory documents accelerate approvals and support patient access. The specialist configures templates and metadata within Roche’s in-house GenAI platform, supports document authors, and ensures outputs are submission-ready. For regulatory professionals, this is a rare chance to combine ICH-CTD expertise with AI-enabled authoring, gaining future-facing skills in regulatory operations and platform governance while contributing to medicines that reach millions.
ROLE DEFINITION & RESPONSIBILITIES
- •Analyze clinical, non-clinical, CMC, and CTD documents and convert them into reusable content components and structured templates.
- •Configure and maintain templates, metadata, and reusable content assets within Roche’s in-house GenAI-powered regulatory authoring platform.
- •Support document authors by drafting and reviewing regulatory documents using AI-enabled authoring capabilities to ensure outputs are accurate, high quality, and submission-ready.
- •Serve as a platform super user, delivering user enablement, business support, and continuous improvement initiatives for regulatory content workflows.
- •Participate in UAT, business validation, and release readiness for new platform capabilities and content governance updates.
- •Collaborate with PDR, Pharma Technical, and Roche Digital Technology stakeholders to align content with regulatory and business needs.
- •Identify automation, low-code/no-code, and AI opportunities to improve regulatory content development efficiency, consistency, and compliance.
- •Maintain version control, template lifecycle management, and content quality standards across regulatory assets.
QUALIFICATIONS & REQUIREMENTS
REQUIRED 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 similar pharmaceutical roles.
- Proven experience supporting clinical or marketing authorization submissions and understanding drug development lifecycle and ICH guidelines.
- Strong knowledge of CTD/eCTD structure and regulatory expectations of FDA, EMA, MHRA, PMDA, or Health Canada.
- Ability to critically review regulatory, clinical, and safety documents and translate them into structured content.
- Familiarity with Generative AI, AI-enabled authoring, RIM, structured content, or content management platforms.
- Experience with UAT, digital platform implementation, business validation, and strong stakeholder communication skills.
PREFERRED QUALIFICATIONS
- •Low-code/no-code platform experience
- •Veeva Vault or similar RIM/authoring systems
- •Automation and digital transformation in regulatory operations
- •Knowledge of FDA/EMA submission publishing
- •Experience training or enabling global regulatory users
REQUIRED VERIFIED SKILLS
Regulatory Affairs & Submissions
ICH-GCP Guidelines
CTD/eCTD Structure
Regulatory Writing & Medical Writing
Generative AI for Regulatory Authoring
Structured Content Authoring
Regulatory Information Management (RIM)
Content Lifecycle & Version Control
User Acceptance Testing (UAT)
Stakeholder Management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Roche is actively hiring for this position.
INDUSTRY: Pharmaceuticals and Diagnostics
EXPECTED CAREER ROADMAP
With 4–6 years of regulatory or medical writing experience, this role builds a strong foundation for senior specialist or lead positions in Regulatory Affairs, Regulatory Operations, or Digital Regulatory Transformation. In 2–3 years, high performers may advance to Regulatory Content Lead, Regulatory AI Product Owner, or Submission Excellence Manager. The AI and structured-content exposure also opens doors to RIM/regulatory technology consulting, pharma digital innovation, and regulatory information management roles. As India’s regulatory operations hubs expand, professionals with CTD, GenAI, and platform implementation expertise are increasingly sought after by global pharma, CROs, and health-tech firms. Long-term options include regulatory affairs director tracks or cross-functional digital product leadership.
APPLICATION ADVISORY
Tailor your resume around regulatory submissions, CTD/eCTD modules, and specific authoring platforms you have used. Highlight examples where you standardized content, improved document quality, or supported UAT and business validation. In interviews, be ready to discuss ICH guidelines, FDA/EMA submission expectations, and how GenAI can responsibly assist regulatory writing. Prepare a short case on converting a complex safety or CMC document into structured templates. Emphasize stakeholder collaboration and your ability to train authors, as Roche seeks a bridge between regulatory expertise and platform adoption.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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