Director of Regulatory CMC

Job not on LinkedIn

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Trilogy

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1989

🚘 Automotive

🛡️ Insurance

📦 Logistics

Automotive • Insurance • Logistics

Trilogy is a comprehensive business platform that helps software companies become more efficient and profitable by streamlining business functions such as development, product management, and R&D. Founded by Stanford dropouts in Silicon Valley in 1989, Trilogy relocated to Austin, Texas in the early 90s and significantly contributed to the city’s transformation into a tech hub. Trilogy focuses on providing high-quality software and unmatched business efficiency managed by the top 1% of global tech talent. The platform offers end-to-end solutions including engineering, customer support, technical product management, finance & accounting, innovation R&D, SaaS operations, renewals, inside sales, and recruiting. By leveraging insights and continuous improvements, Trilogy enables exponential business growth and seamless operations for software companies around the world.

📋 Description

• Lead, mentor, and expand a global team of CMC medical writers and experts • Establish team structure, processes, and operational standards for a newly built CMC capability • Contribute to CMC operating models, processes, and procedural documentation • Represent the CMC team as a senior subject matter expert in client meetings, regulatory strategy discussions, and project scoping • Provide expert input into solutions, assumptions, demand estimates, and costing for client proposals • Participate in and lead pitch meetings • Oversee quality, timelines, compliance with performance metrics, and contractual specifications for CMC deliverables • Contribute hands-on writing or review for high-priority clients or complex CMC documents • Advise strategically on AI-generated CMC outputs from the AI platform • Generate and review CMC outputs and collaborate with the AI development team to improve output quality • Work with Regulatory Strategy, Operations, Manufacturing, Go to Market, and AI platform teams to ensure unified project delivery • Coordinate with Regulatory leadership to expand the team and business

🎯 Requirements

• Extensive experience in CMC operations and writing • Strong familiarity with regulatory expectations across development stages, including new products and life-cycle management of marketed products • Proven leadership experience, preferably at Manager, Senior Manager, or equivalent level, within pharmaceutical or biotech organizations • Demonstrated experience presenting scientific data to internal leadership and/or external partners • Ability to operate confidently as a consultant-level subject matter expert and interact directly with clients • Track record of managing or collaborating with manufacturing sites, QC/QA teams, CROs, and other cross-functional stakeholders • Strong communication skills and comfort with strategic and operational aspects of CMC projects • Strong business acumen and financial understanding of various business models • Experience shaping or evaluating AI-assisted document workflows and outputs • Knowledge of building new service lines or operational structures within regulatory writing • Ability to work in fast-paced, ambiguous, or start-up-like environments while shaping new capabilities • Experience working with international team members • Minimum of a Bachelor's degree in Chemistry, Pharmacy, or a relevant scientific discipline plus a relevant Master's degree • 20+ years of overall experience in CMC operations, writing, and familiarity with regulatory expectations across development stages

🏖️ Benefits

• Equal Employment Opportunity and Inclusion and Diversity commitment • Consideration for employment based on business requirements, merit, and qualifications without discrimination