Skip to main content

Leader Regulatory Affairs CMC (drug substance)

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 CMC Regulatory Consultant specializing in drug substance 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 Regulatory CMC Department is looking for a senior consultant with drug substance development experience, he/she will mainly be responsible for leading the regulatory strategy.

Main Responsibilities:

Job Skills

View the job post & apply

Document Controller

posted by: spj_bot

Image removed.

Join DOF as a Document Controller!

We are looking for several experienced Document Controllers to strengthen and further develop our team and contribute to our success.

As a Document Controller you will play a crucial role in ensuring efficient document control and information management within our Atlantic region. Reporting to our Lead Document Controller in Norway, you will collaborate closely with the Project Manager and Project Technical Managers within the region.

In this role some of your main responsibilities will be to assist the Lead Document Controller in managing and supporting the Document Control requirements in the Atlantic Region. You will use different systems such as ProArc and Unisea, as well as providing training for new users in these. Analyzing the client’s requirements to execute the project and organize activities in line with project administrative requirements will also be an important part of your job.

Job Skills

View the job post & apply

Business Analyst - Gestion Documentaire Pharma

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 offers a great opportunity to contribute to a strategic EDMS transformation program within a global Quality environment. You will play a key role in analyzing complex data landscapes, supporting data-driven decision-making, and shaping the document migration strategy, while working in a highly collaborative and intellectually stimulating environment.

Key responsibiliities :

Job Skills

View the job post & apply

Senior CMC Regulatory (Small Molecules Lifecycle)

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.

Main Responsibilities:

Job Skills

View the job post & apply

Senior CMC Regulatory Technical Writer

posted by: spj_bot

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:

Job Skills

View the job post & apply

Senior Bid Writer

posted by: spj_bot

We are seeking an experienced and driven Senior Bid Writer with a proven track record in the nuclear industry to lead the development of high-quality, compelling bids and proposals. This role requires strong technical acumen, a strategic approach to bid structuring, and the ability to deliver under tight deadlines. Based in Romania, the successful candidate will work closely with cross-functional teams across engineering, commercial, and legal functions both locally and internationally.

Requirements

Key Responsibilities:

Job Skills

View the job post & apply

Administration Assistant

posted by: spj_bot

A fantastic opportunity to join our expanding, close knit Administration team in Burnley town centre. Reporting to the Administration Supervisor, the Administration Assistant will provide fast and effective admin support for our customers and sales teams across the UK.

Duties & Responsibilities

  • Ordering fuel cards for new and existing customers.
  • Inputting card and account details onto database system.
  • Sending cards out to customers with relevant paperwork.
  • Production and distribution of correspondence to customers and colleagues.
  • Stopping/cancelling cards and account closures.
  • Answering calls and dealing with customer enquiries, including transaction queries.
  • Contacting customers regarding cards/transactions.
  • Opening post, answering the intercom and dealing with visitors and deliveries as required.
  • Scanning paperwork using a Document Management system.
  • Any other duties as may be reasonably required.

Requirements

Job Skills

View the job post & apply

Senior Bid Writer

posted by: spj_bot

We are seeking an experienced and driven Senior Bid Writer with a proven track record in the nuclear industry to lead the development of high-quality, compelling bids and proposals. This role requires strong technical acumen, a strategic approach to bid structuring, and the ability to deliver under tight deadlines. Based in Romania, the successful candidate will work closely with cross-functional teams across engineering, commercial, and legal functions both locally and internationally.

Requirements

Key Responsibilities:

Job Skills

View the job post & apply

IT Business Systems Manager - Quality Systems

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for an IT Business Systems Manager – Quality Systems in the United States.

As the IT Business Systems Manager for Quality Systems, you will act as the IT System Owner for GxP-regulated platforms such as Learning Management Systems (LMS), Quality Management Systems (QMS), and Electronic Document Management Systems (eDMS). Your role will focus on supporting compliance-related applications and partnering closely with Quality and Validation teams to ensure the successful configuration, validation, and operation of systems like Veeva Vault Quality and ComplianceWire. You’ll lead both technical and regulatory aspects of IT system management in a hybrid agile/waterfall environment, driving scalable and compliant technology solutions.

Accountabilities:

Job Skills

View the job post & apply
Subscribe to document management system

SPJ is not just a platform; it's a transformative force in the maritime sector. We reinvent job discovery and collaboration, leveraging cutting-edge AI to create a space where careers thrive and innovations set sail.

Featured Posts