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Regulatory Affairs Officer

posted by: spj_bot

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.

We are looking for an experienced Regulatory Affairs Officer to provide temporary, part-time operational support for regulatory activities (BeLux).

The consultant will support the local Regulatory Affairs team with regulatory submissions, marketing authorisation lifecycle management, labelling activities, and regulatory compliance for pharmaceutical products and medical devices.

Key Responsibilities:

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Head of CMC Data Management

posted by: spj_bot

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 lead and shape the Data Management strategy within a global CMC environment. As Head of CMC Data Management, you will drive data governance, lead a team of Data Managers, and prepare CMC data foundations to support future Data Science and Artificial Intelligence initiatives.

Key Responsibilities

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PLM Transformation & Adoption Lead

posted by: spj_bot

Planar is seeking an Engineering/PLM Transformation & Adoption Lead for implementation and adoption of our new PLM module in Microsoft D365 F&O. This position will be a part of initiatives across several business units to modernize engineering systems, data, processes, and connections. The role will focus on Bluestar PLM implementation, change management, communication, training, and adoption across all business units.

This role will work in the IT Enterprise Applications team and work closely with business stakeholders, and external partners to design, implement, support, and continuously improve solutions that drive operational efficiency, process automation, data visibility, and digital transformation initiatives.

Responsibilities

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Senior Product Manager

posted by: spj_bot

Location: Remote - India Remote

Remote | Full-time

Compensation: $75K - $85K

We are hiring on behalf of our client, a fast-growing, enterprise-grade software organization building next-generation infrastructure for institutional applications is seeking a highly skilled and strategic Senior Product Manager to lead its tokenization and capital markets product capabilities.

In this role, the selected candidate will own the strategy, roadmap, and execution for high-growth enterprise features tailored directly to Tier-1 financial institutions, including global banks, asset managers, custodians, and payment networks. Serving as the core product owner for up-market capabilities, this role sits at the intersection of technical innovation and complex institutional requirements—translating deep financial market insights into scalable, production-ready enterprise software.

This position is ideal for a hands-on, high-agency product manager with a substantive background in traditional finance, deep familiarity with market infrastructure, and a proven ability to lead technical discussions with CTOs, Heads of Operations, and enterprise engineering teams.

Key Responsibilities

Job Skills

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Senior Regulatory Affairs CMC (ADC/Biologics)

posted by: spj_bot

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills and recognizes your value.

Our client is looking for a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership support for a global Antibody-Drug Conjugate (ADC) biologics program. The selected consultant will play a critical role in leading global Regulatory CMC activities associated with Marketing Authorisation Applications (MAA) and/or Biologics License Applications (BLA), with a focus on global regulatory CMC strategy and matrix-management leadership.

Missions

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Technology Architect - Remote - Octopus by RTG

posted by: spj_bot

We are seeking a highly experienced Technology Architect to define and govern the organization's Technology Architecture and target technology landscape. The role is responsible for establishing technology standards, principles, platforms, and strategic technology capabilities while ensuring alignment with Enterprise Architecture and business objectives. The Technology Architect will assess the current technology landscape, identify gaps and modernization requirements, define technology roadmaps, and evaluate emerging technologies to support the organization's long-term technology strategy. The role will work closely with Application, Data, Infrastructure, Security, and Enterprise Architects and will contribute to technology governance and strategic technology decisions within a highly regulated banking environment.

YOU WILL

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Infrastructure Architect - Remote - Octopus by RTG

posted by: spj_bot

We are seeking a highly experienced Infrastructure Architect for one of our clients to define and govern infrastructure architecture across cloud, on-premises, and hybrid environments. The role is responsible for designing scalable, secure, highly available, and resilient infrastructure solutions that support enterprise applications and platforms. The Infrastructure Architect will work closely with Cybersecurity, Network, Cloud, DevOps, Application, and Technology teams to ensure infrastructure designs align with Enterprise Architecture, technology standards, business requirements, and applicable regulatory requirements.

Job Skills

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Senior Regulatory CMC Project lead

posted by: spj_bot

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:

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Regulatory Affairs Specialist

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.

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:

Job Skills

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Senior SharePoint Migration Lead (EDMS)

posted by: spj_bot

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 join a dynamic and ambitious team and contribute to a strategic enterprise-wide transformation program. As a Senior EDMS Migration Lead, you will play a key role in shaping the future document management landscape.

Key Responsabilities :

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