Job Title: CMC Subject Matter Expert (Regulatory documentation workflows) Location: India Experience: 8–15+ 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.
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.