At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.

This position offers a unique opportunity to lead strategic CMC regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance. You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of medicines.

Main responsibilities :

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.

This position offers a unique opportunity for a regulatory affairs Manager to lead strategic regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance.

You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of healthcare products.

Main responsibilities :

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.

This position offers a unique opportunity to lead strategic CMC regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance. You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of medicines.

Main responsibilities :

Define and lead the CMC regulatory strategy for complex projects, providing proactive guidance and expertise to cross-functional technical teams

Develop and maintain a global regulatory roadmap, ensuring alignment between manufacturing changes, regulatory requirements, and supply chain constraints

Oversee the preparation and submission of CMC dossiers, ensuring the robustness of comparability, validation, and quality data

Coordinate global regulatory submissions, optimizing timelines and ensuring compliance with regional requirements

Lead and manage interactions with Health Authorities, including addressing technical questions and supporting negotiations to facilitate approvals

About the Job

At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team.

This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.

Main Responsibilities:

Start Your Career in Clinical Research with Excelya

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This is a great opportunity to join and work at Excelya.

Meet us at Domotel Xenia Volos at the Career Day of the University of Thessaly

Are you passionate about Life Sciences and interested in contributing to the future of healthcare and clinical research?

Excelya, a leading Contract Research Organization (CRO) supporting innovative clinical trials worldwide, is looking to connect with motivated students, graduates, and early-career professionals who want to build a career in the clinical research and pharmaceutical industry.

Who we are looking for:

We welcome students, graduates, and early-career professionals with degrees in Life Sciences, including:

• Biology
• Chemistry
• Biomedical Sciences
• Medicine
• Pharmacy
• Biotechnology
• Other relevant Life Science fields

Requirements

About the Job

Join Excelya as a Senior CMC Regulatory Technical Writer, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements.

This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding.

Main Responsibilities:

About the Position

Excelya is seeking a CMC Dossier Preparation Specialist to join our dynamic team. In this role, you will be responsible for the preparation and management of Chemistry, Manufacturing, and Controls (CMC) documents for regulatory submissions. Your contributions will play a crucial role in ensuring compliance with regulatory requirements and supporting the development and lifecycle management of pharmaceutical products.

Your expertise will not only facilitate the timely submission of high-quality CMC documentation but will also help ensure that our products adhere to the highest standards of quality and regulatory compliance.

Main Responsibilities:

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:

Join Excelya, where Audacity, Care, and Energy define who we are and how we work.

We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to join our dynamic and ambitious Pharmacovigilance and Safety team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth 

We are seeking a Senior Safety Officer with a primary focus on the compilation, authoring, and review of aggregate periodic safety reports, including PSURs/PBRERs, DSURs, and ACOs. The role leads the coordination and development of high-quality safety reports including clinical safety evaluations, cumulative safety analyses, and benefit–risk assessments in line with global regulatory requirements. In addition to aggregate reporting and related medical writing activity, the position may support additional pharmacovigilance activities such as risk management, regulatory submissions, compliance oversight, SOPs, training, audits, and CAPA implementation.

Requirements

·       Education: Degree in Life Sciences (Pharmacy, Medicine, Biology, Chemistry); advanced degree (MSc, PhD) is a plus

·       Languages: Fluent in English; French proficiency preferred

About the Job

At Excelya, we embody Audacity, Care, and Energy. We are seeking a dedicated CMC Project Quality Insurance professional to join our team, where you will be instrumental in ensuring quality throughout the CMC (Chemistry, Manufacturing, and Controls) processes. This role provides an exceptional opportunity to work in a supportive environment that prioritizes collaboration and innovation.

In this position, you will work closely with cross-functional teams to uphold the highest quality standards for our CMC projects, facilitating compliance with regulatory requirements and contributing to the overall success of product development.

Main Responsibilities