Regulatory Affairs Coordinator and Archivist
Interimeo
Posted on 27 May
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
- Preparation, printing, and compilation of regulatory files: You will be responsible for gathering and organizing the necessary documents for variations and renewals of our products. You will need to ensure that all required elements are present and correctly formatted.
- Regulatory systems updates: You will be responsible for maintaining and updating the databases and systems used to monitor regulatory requirements. Particular attention must be paid to the accuracy and consistency of the information entered.
- Paper and electronic archiving: you will ensure the proper archiving of regulatory submissions, in accordance with Organon's procedures. This will involve the management and filing of physical documents, as well as the backup and organization of electronic files.
- Shipment tracking: You will track the shipment of regulatory documents and samples to FWA (World Trade Fairs and Exhibitions) countries. You will need to ensure that shipments are made in accordance with regulatory requirements and that all customs formalities are completed.
- Participation in NWA regulatory department projects: you will work in collaboration with members of the regulatory team on various projects aimed at improving processes and ensuring compliance with current regulations.
Comp tences :
- Rigour and good organisation: you must be meticulous and able to manage several tasks effectively while respecting deadlines.
- Team spirit: you will need to collaborate closely with other team members and interact with different stakeholders, so it is important to have good interpersonal skills and be able to work as part of a team.
- Respect for professional secrecy: you will be required to handle confidential information, so it is essential to be discreet and respect the confidentiality of the data.
- Versatility: you will need to adapt to different types of tasks and be able to juggle between varied activities.
Desired Candidate Profile
- The ideal candidate should hold a degree in health, life sciences or medical sciences, or an equivalent degree depending on their training and experience.
- A minimum of one year of experience in regulatory affairs within the pharmaceutical industry is required. Knowledge of pharmaceutical regulations and regulatory file management would be an asset.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Administration
Keywords
- Regulatory Affairs Coordinator And Archivist
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