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CMC Regulatory Expert Biopharma

posted by: spj_bot

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

Job Skills

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Senior Medical Safety Lead

posted by: spj_bot

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 combines scientific expertise with innovation, shaping how safety data is assessed, interpreted, and communicated across a global environment. Ideal for a strategic thinker passionate about advancing signal detection, safety writing, and AI-enabled transformation.

Main Responsibilities:

  • Drive initiatives to enhance Benefit–Risk Assessment & Management (BRAM) practices, tools, and processes
  • Lead and deliver capability-building and transformation projects, from planning to implementation
  • Manage project timelines, milestones, and stakeholder communication
  • Oversee daily activities across signal detection and safety writing workflows (processes, tools, data, documentation)
  • Support continuous improvement of BRAM infrastructure and ensure regulatory compliance
  • Implement process and SOP updates within safety and signal detection systems
  • Collaborate with IT to advance digital transformation (automation, workflow optimisation, AI integration)
  • Apply strong expertise in signal detection and safety writing to ensure high-quality outputs

Requirements

Job Skills

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Senior Environmental Licensing Engineer

posted by: spj_bot

About the Job

Antipollution, a member of Vasileiadis Group of Companies (V Group), is a leading provider of environmental and waste management solutions across the Eastern Mediterranean, Egypt, and the Balkans. Operating across six core business pillars — Port Reception Facilities, Emergency Response Services, Decontamination Services, Renewable Energy, Alternative Fuel Production from Waste, and Technology — we are committed to sustainability, innovation, and operational excellence.

As part of our growing operations, we are seeking a highly motivated Senior Environmental Licensing Engineer to join our team in Piraeus. The role is responsible for supporting and monitoring environmental permitting procedures, ensuring regulatory compliance, and providing technical and licensing support across the company’s projects and facilities.

Role Overview

The Senior Environmental Licensing Engineer contributes to the effective management and monitoring of environmental permitting procedures for the company’s projects and facilities, ensuring compliance with the applicable environmental and regulatory framework. The role supports operational departments by providing technical and regulatory guidance and ensuring the timely and proper implementation of licensing requirements to safeguard operational continuity and environmental compliance.

Job Skills

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Pharmacien(ne) Pharmacovigilance

posted by: spj_bot

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 Pharmacovigilance. 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:

  • Supervise pharmacovigilance case management outsourced to assigned platform(s)
  • Respond to case-related emails and inquiries from external service providers
  • Monitor case processing timelines and investigate any delays in reporting or transmission
  • Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
  • Support the review and validation of clinical study case narratives for inclusion in study reports
  • Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
  • Oversee reconciliation of cases with clinical databases managed by outsourced providers
  • Collaborate closely with cross-functional and global teams to ensure compliance and data integrity

Requirements

Job Skills

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Quality Safety Officer

posted by: spj_bot

Excelya is looking for a motivated Quality Safety Officer to join our dedicated Safety team. As part of our company values of Audacity, Care, and Energy, you will contribute to advancing innovative clinical trials that improve patient outcomes.

In this role, you will oversee quality control activities related to pharmacovigilance processes, ensuring compliance with global regulatory requirements, internal procedures, and industry standards while contributing to continuous quality improvement and patient safety.

Key Responsibilities:

  • Perform quality control reviews of pharmacovigilance cases to ensure accuracy, completeness, and regulatory compliance.
  • Ensure consistency and reliability of safety data entered in pharmacovigilance databases.
  • Manage and navigate pharmacovigilance databases to support case review, follow-up, and data quality activities.
  • Gain proficiency in internal processes and workflows to ensure compliance and operational excellence.
  • Contribute to the continuous improvement of pharmacovigilance quality processes and documentation standards.

Requirements

Education: Bachelor’s degree in Life Sciences, Pharmacy, or a health-related field. Additional training or certification in Pharmacovigilance or Quality Management is a plus.

Job Skills

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Oracle Programmer II

posted by: spj_bot

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 Data Management. 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.

The Oracle Programmer is responsible for providing Oracle Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per Client’s SOPs are delivered to high quality.  

 

Main Responsibilities

Job Skills

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Oracle Programmer I

posted by: spj_bot

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 Data Management. 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.

The Oracle Programmer is responsible for providing Oracle Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per Client’s SOPs are delivered to high quality.  

 

Main Responsibilities

Job Skills

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Sales Director

posted by: spj_bot

Location: Remote - Remote APAC (excluding Hong Kong)

Remote | Full-time

Compensation: $175K - $200K

We are hiring on behalf of our client, an innovative technology organization specializing in next-generation enterprise networks and advanced asset tokenization software is seeking an experienced, high-performing Sales Director to lead institutional and enterprise business development efforts across the Asia-Pacific (APAC) region.

This strategic role is focused on driving new revenue growth within the financial services sector by positioning complex private network architectures, asset tokenization software, and advanced market infrastructure solutions built on institutional-grade distributed ledger technology (DLT). The ideal candidate possesses deep experience in high-value enterprise technology sales, coupled with a sophisticated understanding of blockchain, DLT use cases, and the regulatory frameworks governing digital assets and financial networks.

Job Skills

professional regulatory compliance validation brand security policy mobility sales risk assessments financial services target value proposition technology architecture relationship management governing maintain disciplined tokenization partner management distributed systems forecast management sale management professional service private network localization negotiation cross functional collaboration distill operational sales cycles revenue forecasts value enterprise closing enterprise networks technology solution financial value add reseller revenue growth target account technical acumen network architecture business priority managed securely communication skills digital asset procurement business development blockchain account planning economic innovation literacy interoperability service sector innovative adoption financial institution targets accounts negotiation contract financial service articulation use cases infrastructure advanced communication applicable data regulated financial c emerging market sales cycle presentation remote remote cloud infrastructure manage track
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Logistics Coordinator

posted by: spj_bot

Image removed.

Join DOF as our Logistics Coordinator

The Logistics Coordinator oversees complex logistics operations supporting subsea oil and gas projects, including offshore mobilizations, equipment movements, international shipments, and compliance with industry‑specific regulatory requirements. This role ensures that critical subsea assets, tooling, and materials are delivered safely, efficiently, and on schedule to support project execution in offshore and onshore environments. 

The ideal candidate brings deep experience in energy-sector logistics, strong vendor and vessel coordination skills, and the ability to manage high‑stakes timelines where delays directly impact operational readiness. 

Image removed.

Job Skills

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Clinical Research Associate Oncology

posted by: spj_bot

About the Job

Excelya invites you to join a team defined by Audacity, Care, and Energy. We foster bold innovation and support a collaborative environment where personal and professional growth thrive.

As a Clinical Research Associate at Excelya, you will be integral to ensuring the successful execution of clinical trials by overseeing site activities, adherence to protocols, and regulatory compliance. This role is pivotal in advancing clinical projects that aim to improve patient care.

Main Responsibilities:

  • Conduct site initiation, monitoring, and close-out visits to ensure compliance with clinical trial protocols.
  • Maintain effective communication with investigators and site staff to support trial progress.
  • Review and verify clinical trial data and documentation for accuracy and completeness.
  • Monitor patient safety and data integrity throughout the study duration.
  • Assist in preparation for audits and inspections, ensuring sites are inspection-ready.
  • Report deviations, adverse events, and other study-related issues in a timely manner.
  • Collaborate with project managers to provide updates and address challenges encountered at sites.

Requirements

Requirements:

Job Skills

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