CMC Regulatory Consultant / Senior Consultant – Cell and Gene Therapy (Hybrid)
Updated: February 3, 2026
Location: Hybrid – Serbia, Spain, United Kingdom, or Portugal
Primary Posting Location: London, United Kingdom
Job ID: 25103768-OTHLOC-3666-2DH
Employment Type: Full-Time | Hybrid Model
Job Overview
Syneos Health® is a globally integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercial success for innovative therapies worldwide. With operations spanning over 110 countries and a workforce of more than 29,000 professionals, Syneos Health partners with sponsors to accelerate regulatory approvals and patient access.
We are seeking a CMC Regulatory Consultant / Senior Consultant – Cell and Gene Therapy to support global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for advanced therapy medicinal products (ATMPs), including cell and gene therapies. This role is critical to the preparation, review, and submission of high-quality regulatory CMC documentation across development and commercial lifecycle stages.
The position is available in a hybrid working model and open to candidates based in Serbia, Spain, the United Kingdom, or Portugal.
Key Responsibilities
Regulatory CMC Strategy and Execution
Support the development and execution of global regulatory CMC strategies for cell and gene therapy products across development and marketed phases.
Contribute to CMC sections of regulatory submissions, including INDs, IMPDs, CTAs, BLAs, MAAs, and post-approval variations.
Ensure alignment of CMC documentation with EMA, FDA, and global regulatory requirements applicable to ATMPs.
Cross-Functional Regulatory Support
Provide regulatory CMC guidance to cross-functional teams, including Manufacturing, Quality, Process Development, Analytical, and Supply Chain.
Support regulatory impact assessments for process changes, comparability strategies, and lifecycle management activities.
Ensure regulatory considerations are embedded throughout development and commercialization plans.
Documentation and Compliance
Author, review, and manage CMC regulatory documentation to ensure accuracy, consistency, and compliance with applicable guidelines.
Support health authority interactions related to CMC topics, including preparation of responses to regulatory questions.
Maintain awareness of evolving global CMC and ATMP regulatory landscapes.
Continuous Improvement and Knowledge Sharing
Contribute to internal best practices, templates, and process improvements related to regulatory CMC activities.
Support regulatory intelligence efforts relevant to cell and gene therapy development.
Required Qualifications and Experience
Education: Bachelor’s degree or higher in Life Sciences, Chemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline. Advanced degree preferred.
Experience:
Consultant level: Minimum 5+ years of experience in Regulatory CMC within pharmaceutical, biotechnology, CRO, or consultancy environments.
Senior Consultant level: Minimum 7–10+ years of direct Regulatory CMC experience, including leadership of complex submissions.
Demonstrated experience supporting cell and gene therapy or advanced therapy medicinal products (ATMPs).
Strong knowledge of global CMC regulatory requirements, including EMA, FDA, and ICH guidelines.
Experience contributing to regulatory submissions and lifecycle management activities.
Ability to work effectively in cross-functional, matrixed, and global teams.
Strong written and verbal communication skills in English.
Why Join Syneos Health?
Over the past five years, Syneos Health has supported 94% of all novel FDA-approved therapies and 95% of EMA-authorized products, delivering more than 200 clinical studies across 73,000 sites and 675,000+ patients globally.
At Syneos Health, professionals benefit from:
Structured career development and technical training
Exposure to cutting-edge cell and gene therapy programs
A collaborative, inclusive, and globally connected culture
Flexible hybrid working arrangements across key European locations
Additional Information
Job responsibilities may evolve based on business needs. Equivalent education, experience, or qualifications may be considered. This job description does not constitute an employment contract. Syneos Health is an equal opportunity employer and complies with all applicable employment and disability legislation across its operating regions.
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