Regulatory Affairs and Quality Assurance Coordinator

Il y a 2 mois


Brussels, Belgique Oxford Global Resources Temps plein

**Regulatory Affairs and Quality Assurance Coordinator**:

- Location:
Brussels, Belgium
- Contact:
Aurore Munaut
- Job type:
Contract
- Contact phone:
+32 10685331
- Industry:
Pharmaceutical

Reporting to the Head or RA/QA, the Regulatory Affairs (RA) and Quality Assurance (QA) Coordinator is responsible for executing operational administrative RA and QA activities.

**Responsibilities**
- Assists the Head of RA-QA, RA Manager/Officer upon preparation of the registration dossier, updates and/or variations thereof for submission at the Belgian and Luxembourg health authorities:

- modification of Module 3 documentation in line with the instructions of the RA Manager/Officer
- use of the documentation databases MOSAIC and Sheds according to the current processes and procedures
- creation of the electronic submission documents (NeeS + eCTD)
- archiving of all correspondence (internal and authority correspondence)
- creation of consolidated Module 3 approved dossier (both paper and electronic version)
- Organising and review of translations of the product information (NL, FR, DE, EN).
- Collect answers and respond to regulatory authorities questions within required timelines.
- Verification and approval of packaging material:

- use of the electronic databases EAMS and SAMS for control, correction and final approval of packaging material.
- management of EAMS mailbox
- review, evaluation and archiving of packaging material received by mail (non EAMS).
- Review and correction of product information on Compendium portal
- Update of internal databases (e.g. product database) and creation of such databases upon necessity.
- Request of modifications and review of the changes made in registration tool PRISM and registration tool GRACE.
- Update request of XEVMPD database
- Manage requests for certificates like e.g. CPPs, GMPs, and copies of MIAs in close collaboration with the Health authorities and the requestor
- Assisting Head of RA-QA, QA Manager, QA administrator with support for communication due to complaints and/or recalls.
- Supporting the QA team with internal classification of documents.
- Management of Batch Inspection Records (BIRs):

- creation of new or updated BIRs due to changed packaging materials and/or other applicable information
- management of BIR mailbox
- archiving of paper BIRs with signed feedback from RA/QA dept
- Management of invoices from the RA/QA department:

- review of invoices and communication with internal and external stakeholders
- creation of related PO in SAP
- request of 'proof of payments' for specific dossier
- management of systems to control the budget

**Requirements**:

- Bachelor or equivalent combination by education and experience
- Experience as a Regulatory Affairs and/or Quality assistant is an asset
- Good spoken and written communication skills
- Understanding of the activities and practices within the dedicated department(s)
- Fluent (written and spoken) in Dutch, French and English
- Accuracy
- Integrity/confidentiality
- Flexibility
- Customer/Market minded
- Showing initiative
- Planning and organization
- Existing right to work in Europe required

**Benefits**
- Short term opportunity - mid March till mid July 2023
- Balanced salary package based upon your experience and capabilities



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