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 Regulatory. 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:

• Ensure that all information and publicity materials related to medicinal products or healthcare products comply with applicable regulatory requirements
• Review and approve communication materials intended for healthcare professionals or the general public (e.g. brochures, digital content, training materials, press releases)
• Verify the scientific accuracy, consistency, and balance of product-related information
• Ensure communications are aligned with approved indications and regulatory approvals
• Act as a key contact between Regulatory Affairs, Medical, Marketing, and external partners
• Contribute to risk prevention by avoiding misleading, promotional, or non-compliant communications
• Monitor regulatory changes impacting information and publicity requirements

Requirements

Join Excelya as a Medical Advisor in our team !

At Excelya, we are committed to delivering innovative clinical research solutions across Europe. As a Medical Advisor, you will play a pivotal role in providing expert medical and scientific guidance to support several projects internnaly.

Key Responsibilities:

• Provide medical expertise and advice throughout clinical development processes.
• Support the preparation and review of medical and scientific content including manuscripts, posters, and presentations.
• Engage with cross-functional teams to ensure scientific accuracy and relevance of clinical trial materials.
• Assist in medical training, promotional material review, and respond to medical inquiries.
• Stay up to date with therapeutic area trends and scientific advancements.

Requirements

Candidate Profile:

• Pharmacist or Phd or equivalent in Life Sciences.
• Experienced in medical affairs, medical information, or related field, preferably within the pharmaceutical or clinical research industry.
• Strong knowledge of clinical research methodology and medical communications.
• Excellent written and verbal communication skills in English;

Benefits

Why Join Us?

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:

Position Overview

Excelya is seeking a dedicated Data Owner Support professional to join our growing Data Management team. In this role, you will collaborate closely with Data Owners to ensure data quality, governance, and compliance while supporting the execution of data-related strategies within clinical research and drug development projects.

As part of an innovative and dynamic company, you will contribute to enhancing data processes and help shape the future of data management in the pharmaceutical and life sciences sector.

Key Responsibilities

Step into an exciting opportunity at Excelya, a leading Contract Research Organization (CRO) dedicated to advancing healthcare through innovative clinical research. Join our dynamic team as a Clinical Contract Associate and contribute to managing clinical contracts that enable groundbreaking studies worldwide.

The role focuses on preparing, reviewing, negotiating, and tracking Clinical Trial Agreements (CTAs) and related documents in alignment with Legal guidance and internal company policies. The Clinical Contract Associate acts as a key operational interface between Clinical Operations, Legal, Procurement, Finance, Compliance, service providers, and clinical sites.

Key Responsibilities:

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to support the deployment and validation of a new scientific data platform within a leading pharmaceutical R&D environment. You will work closely with Data Management, Product Owners, Business stakeholders, and technical teams to ensure the successful implementation and adoption of the VIVO ecosystem.

Key Responsibilities:

• Support the deployment, testing, and validation of the VIVO platform (Benchling) and its functionalities.
• Perform data consistency checks between Benchling, VIVO DB, LIMS, BI reports, and FederateS.
• Review and validate operational data imported from laboratory systems.
• Support Product Owners and Business Owners in prioritizing product enhancements and implementation activities.
• Execute UAT and sprint-related testing activities based on defined test plans.
• Analyze business requirements and contribute to process improvements.
• Document system changes, validation activities, and user guidance materials.
• Participate in Agile/SCRUM ceremonies and collaborate with multidisciplinary teams.

Requirements

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 Regulatory affairs department. 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.

Responsibilities :

Reporting to the Registration Department Team Manager, you are responsible for all activities related to the obtention, follow-up and maintenance of Marketing Authorizations (MA) in France and Europe, including:

• Submission and follow-up of Marketing Authorization applications at both national and European levels.
• Preparation, submission and follow-up of regulatory evaluations with Competent Authorities for: pharmaceutical variations, MA renewals, Requests for Amendments to Product Information (DMI), regulatory variations, up to their practical implementation.
• Monitoring product registration in the Generic Groups Directory.
• Acting as an interface with internal departments, external experts, API manufacturers and contract manufacturing organizations (CMOs).

Requirements

Education : Qualified Pharmacist or a Master’s degree

About the Role

Excelya is looking for a motivated and strategic BMK Strategy Lead to drive biomarker strategy development and execution across clinical research programs. As the BMK Strategy Lead, you will lead and drive the biomarker strategy to support project development from lead optimization through life‑cycle management, in close collaboration with project teams and internal/external partners.

Key Responsibilities

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

Mains Responsibilities :

The position involves performing as Local Contact Person responsible for Pharmacovigilance for Paris and participating in local/global projects within the Pharmacovigilance (PV) and Safety department.

Work in several aspects of pharmacovigilance shall be expected, such as

Manage pharmacovigilance (PV) case processing, including receipt, acknowledgement, coding (MedDRA), seriousness assessment, and timely forwarding to the external PV provider.

Conduct follow‑up activities with reporters to obtain additional case information.

Handle increased PV case volumes during Early Access Programs (ATU/AAP).

Perform regular reconciliations with multiple stakeholders (PV vendor, MedInfo, QA, DSE, Business Partners, CRM, Market Research agencies, ATU/AAP provider, Global MedInfo).

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 Regulatory Affairs 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

The role is part-time and involves performing as Local Regulatory Affairs Expert providing consultancy services related to marketing authorizations and supporting regulatory activities for pharmaceutical products in Malta. Furthermore they must be able and willing to legally work as a Freelancer and be based and have experience working in Malta.

Work in several aspects of regulatory affairs shall be expected, such as: