About the Job
Join Excelya as a CMC Specialist and become an integral part of a dedicated team that values Audacity, Care, and Energy. In this role, you will contribute to the CMC regulatory strategy and support the development, manufacturing, and lifecycle management of pharmaceutical products.
Your expertise will help to ensure compliance with regulatory requirements while facilitating the delivery of innovative therapies to patients. You will be part of a stimulating professional environment where personal and intellectual growth is encouraged.
Main Responsibilities:
- Support the preparation, review, and submission of regulatory documentation related to Chemistry, Manufacturing, and Controls (CMC) for drug development and marketed products.
- Collaborate with cross-functional teams including R&D, Quality Assurance, and Manufacturing to develop and implement CMC strategies.
- Assess regulatory impact of changes in manufacturing processes and provide recommendations for compliance.
- Assist in responding to regulatory inquiries and follow up with health agencies on CMC matters.
- Monitor industry trends and regulatory updates to ensure compliance with evolving guidelines.
- Support continuous improvement initiatives within the CMC function.
Requirements
Candidate Profile:
- Experience: Relevant experience in CMC regulatory affairs or related areas within the pharmaceutical industry.
- Skills: Strong understanding of CMC regulatory requirements and processes. Excellent analytical, organizational, and communication skills.
- Education: Degree in pharmaceutical sciences, life sciences, or a related field.
- Languages: Proficiency in English is required; knowledge of French is a plus.
- Demonstrates attention to detail, initiative, and the ability to work collaboratively in cross-functional teams.
Benefits
Why join us ?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique—
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
Top Skills
What We Do
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of Full-service CRO, FSP, and Resourcing solutions guided by compassion, care, and excellence.
Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.
