Director of Regulatory CMC

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Lead, mentor, and grow a global team of CMC medical writers and specialists

• Develop team structure, processes, and operational standards for a newly established CMC capability

• Contribute to CMC operating models, processes, and procedural documentation

• Serve as a senior subject matter expert representing the CMC team in client meetings, regulatory strategy discussions, and project scoping

• Provide expert insights into solutions, assumptions, demand estimates, and cost projections for client proposals

• Participate in and lead pitch meetings

• Ensure quality, timelines, compliance with performance metrics, and contractual obligations for CMC deliverables

• Engage in hands-on writing or review for key clients or complex CMC documents

• Provide strategic advice on AI-generated CMC outputs from the AI platform

• Produce and evaluate CMC outputs and collaborate with the AI development team to enhance output quality

• Collaborate with Regulatory Strategy, Operations, Manufacturing, Go to Market, and AI platform teams to ensure cohesive project delivery

• Work with Regulatory leadership to enhance the team and business

⛳️ Requirements

• Extensive experience in CMC operations and writing

• Strong familiarity with regulatory expectations throughout development phases, including new products and lifecycle management of marketed products

• Proven leadership experience, ideally at the Manager, Senior Manager, or equivalent level, within pharmaceutical or biotech organizations

• Demonstrated experience in presenting scientific data to internal leadership and/or external partners

• Ability to confidently operate as a consultant-level subject matter expert and engage directly with clients

• Proven history of managing or collaborating with manufacturing sites, QC/QA teams, CROs, and other cross-functional stakeholders

• Excellent communication skills and comfort with both strategic and operational aspects of CMC projects

• Strong business acumen and financial understanding of various business models

• Experience in shaping or assessing AI-assisted document workflows and outputs

• Knowledge of establishing new service lines or operational structures within regulatory writing

• Ability to thrive in fast-paced, ambiguous, or start-up-like environments while developing new capabilities

• Experience working with international teams

• Minimum of a Bachelor's degree in Chemistry, Pharmacy, or a related scientific discipline, along with a relevant Master's degree

• Over 20 years of experience in CMC operations, writing, and familiarity with regulatory expectations across development stages

🏝️ Benefits

• Commitment to Equal Employment Opportunity and Inclusion and Diversity

• Employment considerations based on business needs, merit, and qualifications without discrimination