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:

À propos du poste

Rejoignez Excelya, où l'Audace, le Care et l'Énergie définissent qui nous sommes et la manière dont nous travaillons. Nous croyons en la création de solutions audacieuses et en un environnement inclusif, où la collaboration et le développement individuel avancent main dans la main.

Missions principales:

• Définir et mettre en œuvre la stratégie de biocompatibilité selon ISO 10993 et réglementations applicables (MDR, FDA si pertinent)
• Élaborer et maintenir le Biological Evaluation Plan (BEP) et le Biological Evaluation Report (BER)
• Identifier les essais nécessaires pour un dispositif implantable longue durée
• Assurer la cohérence scientifique et réglementaire de l’évaluation biologique
• Planifier, budgéter et suivre les activités d’essais
• Sélectionner et coordonner les laboratoires sous-traitants
• Superviser les échantillons de test avec les équipes R&D; et production
• Analyser et interpréter les résultats d’essais
• Rédiger et maintenir la documentation technique associée
• Contribuer au Technical Documentation / Design Dossier
• Garantir la conformité ISO 13485
• Contribuer aux investigations de non-conformités liées aux matériaux
• Renforcer le contrôle fournisseur sur les matières premières critiques
• Participer à l’amélioration continue du système qualité

Requirements

About the Job

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.

You will be responsible for the medical assessment of sensitive pharmacovigilance files, often consisting of numerous medical documents. Expertise in neurology, obstetrics‑gynecology, or pediatrics is particularly valuable.

Your role will be to produce clear, accurate, and clinically rigorous medical summaries, supporting medico‑legal evaluations within the context of compensation requests.

Main Responsibilities:

About the Job

Join Excelya, where Audacity, Care, and Energy define how we support our clients and how we grow together. We believe in building bold solutions and fostering an inclusive environment where collaboration, responsibility, and personal development are central.

This role is an exciting opportunity to join our Clinical Quality Assurance team. As a key contributor, you will ensure that clinical research activities are conducted in full compliance with international regulations, internal standards, and industry best practices. You will help drive continuous improvement, strengthen our quality culture, and support teams through a stimulating and supportive professional environment.

Main Responsibilities:

About the Job

As a Gidy Expert Qualification at Excelya, you will be at the forefront of ensuring compliance and qualification for innovative solutions within the biopharmaceutical landscape. This unique role involves a deep understanding of regulatory standards and the application of best practices in qualification processes.

You will work closely with our teams to design, implement, and optimize qualification protocols that align with our clients' needs and maintain the highest quality and safety standards in their processes.

Main Responsibilities:

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking a Technical Data Manager, who will be responsible for performing Technical Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs.

Main Responsibilities:

About the Job

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 contribute to a dynamic, ambitious team in Medical affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

• Act as lead author for a range of regulatory and scientific documents (clinical protocols, Investigator Brochures, CTD modules, informed consent forms, etc.).
• Coordinate cross-functional input (clinical, regulatory, biostatistics, data management, etc.) to ensure consistency and scientific accuracy of all deliverables.
• Oversee and review the work of external vendors or contributing writers to ensure quality and compliance.
• Ensure documents adhere to company SOPs, style guides, and international regulatory standards (EMA, FDA, ICH).
• Manage timelines, planning, and document reviews efficiently to support submission milestones.

Requirements

About You

About the Job

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 contribute to a dynamic, ambitious team in Bangalore. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

1.      Responsible for programming using DMW Oracle and Oracle OAC.

2.     Will design the data model in DMW according to sponsor standards.

3.     Responsible to write data transfer protocol for external data vendors integration from specifications provided by Sponsor

4.     Responsible to manage external data loading and integrations in DMW

5.     Archives Data Management programming documentation. 

Requirements

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

Experience: 3 years or more years as OP or equivalent combination of education, training, and experience 

Skills:  

About the Job

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 contribute to a dynamic, ambitious team in Bangalore. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Requirements

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

Experience:  

One or more years as a Data Manager or equivalent combination of education, training and experience

Skills:  Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance

• Experience in clinical trial databases and applications, clinical data flow, data review, and eCase Report Form design.
• Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout)

Education: Bachelor’s degree qualification in a Scientific discipline is preferred

About the Job

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 contribute to a dynamic, ambitious team. You will play a critical part in driving innovatio and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Activities