Job Title: CMC Subject Matter Expert (Regulatory documentation workflows)
Location: India
Experience: 815+ years
Domain: Pharma / Biologics / Regulatory CMC
Role type: Contract role only to start
At Replicant AI, we're building an AI-first documentation platform for life sciences starting with one of the most complex and high-impact areas: Module 3 (CMC) of the regulatory dossier.
We're looking for a hands-on CMC Subject Matter Expert who deeply understands regulatory documentation and workflows, and is excited to shape how AI products are built for real pharma users.
Roles & responsibilities
- Act as the CMC domain expert for our AI product, covering Module 3 (3.2.S / 3.2.P) end-to-end
- Provide deep insight into documentation types, data dependencies, and authoring workflows, including:
Drug Substance & Drug Product sections
Manufacturing processes & controls
Specifications, analytical methods, validation
Stability, comparability, lifecycle management
- Translate real-world CMC workflows into AI-ready product requirements
- Partner closely with product managers, AI engineers, and prompt designers
- Review and validate AI-generated outputs for regulatory accuracy, completeness, and intent
- Help define use cases, edge cases, and future roadmap for CMC automation
- Bring a reviewer / regulator mindset to improve robustness and defensibility of outputs
Qualifications:
- Strong experience owning or contributing to Module 3 regulatory submissions (US FDA, EMA, MHRA, WHO, etc.)
- Background in innovator, generics, biologics, or CRDMO environments
- Deep familiarity with CMC authoring, review, and lifecycle updates
- Ability to think structurally about documents, not just write them
- Curiosity and comfort working with AI tools, automation, or digital platforms
- Clear communicator who can bridge science, regulation, and product design
- Prior collaboration with IT, SaaS, or digital transformation teams
Why work with Replicant AI
- You won't just use software you'll help define how AI understands CMC
- Direct influence on a core life-sciences AI product, not a side project
- Opportunity to apply decades of CMC knowledge at platform scale
- Work with a founding team deeply focused on real pharma problems, not generic AI demos
If you've spent years navigating Module 3 and now want to multiply your impact through AI, we'd love to talk.
