Administrative Coordinator- Regulatory Affairs
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands.
The Admin Regulatory Affairs will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation. You will work in collaboration with the Site RA CMC and other Global/Regional Teams as needed.
- Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository.
- Supports the Site Regulatory CMC in the compilation and preparation of marketing application and post-approval submissions as needed.
- Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
- Strong written and oral communication skills
- Proficient use of MS Office tools, SharePoint and strong computer aptitude.
- Must have ability to work within team environment, but maintain a level of autonomy for managing daily tasks and activities
- Solid working knowledge on document management systems such as Documentum.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
The Company
They are proud to be known for our extremely reliable delivery of medicines to our patients. We are one of the biggest biotech pharmaceutical companies that develops and introduces more and more new medicines to serve patients all over the world. In combination with our primary focus on affordable healthcare, we are constantly improving our production systems & processes. Our manufacturing environment is growing in a fast pace in terms of production volumes, -variability and complexity.Role Description
The Admin Regulatory Affairs is responsible for the registration document(s) procurement, preparation and coordination.The Admin Regulatory Affairs will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation. You will work in collaboration with the Site RA CMC and other Global/Regional Teams as needed.
Responsibilities
- Coordinates legalization and delivery of registration documents following the instructions provided in the request.- Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository.
- Supports the Site Regulatory CMC in the compilation and preparation of marketing application and post-approval submissions as needed.
- Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
Requirements
- Knowledge of Good Manufacturing Practices (GMP) and good documentation practices is a pre- Strong written and oral communication skills
- Proficient use of MS Office tools, SharePoint and strong computer aptitude.
- Must have ability to work within team environment, but maintain a level of autonomy for managing daily tasks and activities
- Solid working knowledge on document management systems such as Documentum.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
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