Global CMC Director & AI-Enabled Regulatory Leader

Trilogywriting; United Kingdom; Remote; GBP 120,000 - 180,000; Full time

Job summary

Indegene is seeking a senior leader to head the CMC writing team within Regulatory Services, combining hands-on CMC expertise with strategic client engagements. You will shape best practices for AI-assisted CMC content and work closely with clients and internal teams to advance capabilities.

The role requires leading a growing global team, ensuring high-quality deliverables, and collaborating across regulatory, manufacturing, and go-to-market functions to drive collective success.

Qualifications

• 20+ years of experience in CMC operations, writing, and regulatory expectations across development stages (new products and lifecycle management).
• Proven leadership experience at Manager/Senior Manager level within pharma or biotech.
• Experience presenting scientific data to internal leadership and external partners.
• Ability to act as a consultant-level SME and interact directly with clients.
• Track record of collaborating with manufacturing sites, QC/QA, CROs and cross-functional stakeholders.

Responsibilities

• Lead, mentor, and expand a global CMC medical writing team; establish structure and standards for a new CMC capability.
• Represent the CMC team in client meetings, regulatory strategy discussions, and project scoping; contribute to proposals and costing.
• Oversee quality of CMC deliverables and ensure timelines and contractual compliance; provide hands-on writing/review for priority clients.
• Advise on AI-generated CMC outputs; drive development of outputs with AI platform team to improve quality.
• Collaborate with Regulatory Strategy, Operations, Manufacturing, GTM and AI platform teams to ensure unified delivery across projects.

Skills

CMC leadership

Regulatory writing

Client-facing

AI collaboration

Project management

Education

Bachelor’s degree in Chemistry/Pharmacy or related

Master’s degree in relevant field

Job description

Indegene is seeking a senior leader to head the CMC writing team within Regulatory Services, combining hands-on CMC expertise with strategic client engagements. You will shape best practices for AI-assisted CMC content and work closely with clients and internal teams to advance capabilities.

The role requires leading a growing global team, ensuring high-quality deliverables, and collaborating across regulatory, manufacturing, and go-to-market functions to drive collective success.