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.

The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to manage and deliver the CMC Dossier with the support of the technical writing team within the Regulatory CMC.

Main 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.

Provide operational regulatory support to a pharmaceutical affiliate in Greece, with primary responsibility for the maintenance and lifecycle management of national Marketing Authorisations (MAs), particularly for an oncology product. The role also supports regulatory activities across several European distributor markets.

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 :

Rejoignez Excelya, où l'Audace, le Soin et l'Energie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Dans le cadre du renforcement de ses activités de gouvernance des données au sein d'un environnement pharmaceutique international, nous recherchons plusieurs Data Owner Support pour accompagner les équipes métiers dans la structuration, la qualité et la conformité de leurs données stratégiques. Vous jouerez un rôle clé à l'interface entre les équipes Business, IT et Data Governance afin de garantir une gestion efficace, fiable et conforme des données tout au long de leur cycle de vie.

Rejoignez Excelya, où l'Audace, le Soin et l'Energie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Ce poste représente une opportunité stimulante de rejoindre une équipe dynamique et ambitieuse.

Dans le cadre du renforcement de ses activités Data au sein d'un environnement pharmaceutique international, nous recherchons un(e) Data Manager CMC pour assurer la gestion opérationnelle, la qualité et la valorisation des données liées aux activités de Chemistry, Manufacturing & Control (CMC). Vous contribuerez à la fiabilisation des données, à leur intégration dans les systèmes de l'entreprise et à l'amélioration continue des processus de gestion des données au sein d'équipes pluridisciplinaires.

Come Join Our Team! First Division Consulting (FirstDiv) provides program management, acquisition, logistics, field service representative, explosive ordnance disposal, and personnel support services to Department of Defense and Federal Government Agencies. We are a Small Business Administration certified Service-Disabled Veteran-Owned Small Business and a Small Disadvantaged Business. If you are looking for a company who has an overall rating on Glassdoor of 4.8 and who puts their people first, then continue to read below and join the FirstDiv team!

**Position is contingent upon contract award

First Division Consulting, Inc. is seeking an Expeditionary Operations & Technical Exploitation Subject Matter Expert (SME 2) to provide technical and operational support to EXU-1.

The SME 2 applies specialized knowledge and analytical expertise to expeditionary operations, technical programs, institutionalization, capability development, and other assigned EXU-1 mission requirements. The position independently manages or supports intricate projects and may supervise or train junior personnel.

Key Responsibilities

·   Apply specialized technical knowledge and analysis to assigned EXU-1 projects and mission requirements.

·   Plan, organize, control, supervise, or manage intricate projects or multiple related activities.

Come Join Our Team! First Division Consulting (FirstDiv) provides program management, acquisition, logistics, field service representative, explosive ordnance disposal, and personnel support services to Department of Defense and Federal Government Agencies. We are a Small Business Administration certified Service-Disabled Veteran-Owned Small Business and a Small Disadvantaged Business. If you are looking for a company who has an overall rating on Glassdoor of 4.8 and who puts their people first, then continue to read below and join the FirstDiv team!

**Position is contingent upon contract award

First Division Consulting, Inc. is seeking an Expeditionary Operations & Technical Exploitation Subject Matter Expert (SME 1) to support the EXU-1 Command Operational and Technical Support mission.

The SME 1 provides specialized technical and operational expertise supporting multifaceted projects and mission activities across one or more EXU-1 functional areas. The position requires an experienced professional capable of independently executing assigned tasks, coordinating with technical and operational personnel, and contributing to mission-focused analysis and deliverables.

Key Responsibilities

·   Provide technical knowledge and specialized support within assigned mission or functional areas.

·   Plan, organize, supervise, execute, or manage multifaceted projects or sets of related activities.

At Excelya, driven by Audacity, Care, and Energy, we invite you to join our team as a Clinical Quality Manager. This pivotal role focuses on overseeing the quality management system within clinical operations to ensure compliance with regulatory requirements and continuous improvement of clinical processes.

As a Clinical Quality Systems coordinator, you will be responsible for implementing & maintaining relevant QMS to assure the Commercial Operations groups are fully compliant and efficient with Global GxP’s

Your 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 :

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 :