Serbia Hybrid

Syneos Health is hiring a CMC - Regulatory CMC Consultant / Snr Consultant Cell and Gene Therapy (Serbia/Spain/UK/Portugal) )Hybrid

We are seeking a dedicated Chemistry Manufacturing and Controls (CMC) Consultant or Senior Consultant to help advance cell and gene therapy programs through strategic regulatory planning. In this hybrid role based in Serbia, Spain, the UK, or Portugal, you will play a key part in shaping global CMC strategies for both in-development and marketed therapies.

Key Responsibilities

  • Support the implementation of regulatory CMC strategies for cell and gene therapy products worldwide
  • Lead the preparation and submission of high-quality regulatory documentation aligned with global standards
  • Collaborate with multidisciplinary teams to integrate regulatory requirements into product development and commercialization plans
  • Advise internal stakeholders on evolving regulatory expectations across regions
  • Ensure compliance with applicable international guidelines throughout the product lifecycle

Our Culture and Benefits

We foster an environment where diverse perspectives are valued and every individual is empowered to contribute. Our culture emphasizes personal growth, inclusivity, and innovation in addressing complex challenges in healthcare.

  • Comprehensive training in regulatory science and therapeutic areas
  • Opportunities for career advancement and professional recognition
  • A supportive management structure focused on employee development
  • Flexible work model promoting work-life balance
  • Inclusive environment that encourages authentic participation
  • Exposure to cutting-edge science, data, and emerging technologies

We are committed to creating accessible opportunities and providing reasonable accommodations for qualified individuals. This role reflects our mission to build a workplace where people thrive, innovate, and drive meaningful impact in medicine.

Required Skills
Regulatory CMC documentationGlobal regulatory submissionsCell and gene therapy developmentChemistry Manufacturing Controls (CMC)Regulatory strategy for biopharmaceuticalsCMC documentation preparationCross-functional regulatory guidanceGlobal regulatory requirementsBiopharmaceutical industry experienceRegulatory compliance Regulatory CMCCell TherapyGene TherapyBiopharmaceuticalsClinical Development
About company
Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company combines unique clinical, medical affairs, and commercial insights to deliver outcomes that address modern market realities.

It provides end-to-end services across clinical development, medical affairs, and commercial delivery, supporting biopharma innovation from concept to market. Its integrated approach spans consulting, clinical trials, regulatory and safety, commercialization, and market access.

Syneos Health specializes in therapeutic areas including oncology, neuroscience, cardiovascular, immunology, infectious diseases, and rare diseases, with a focus on accelerating the development and launch of new therapies.

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Posted 4 months ago