CMC Subject Matter Expert

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 , were 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.

Were 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 wont just use software youll 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 youve spent years navigating Module 3 and now want to multiply your impact through AI , wed love to talk.