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ARCQ

Regulatory Affairs Associate

Via ARCQ

Staat 12 dagen op Jobat.be

Providing smart staffing solutions to the life sciences, chemical and food industries is what we are good at.
Our exclusive focus gives us a sharper edge, and our commitment to quality implies we recruit only the best. 
We guarantee discretion, integrity and transparency.  
Moreover, we value and nurture a culture of enthusiasm, professionalism and commitment. 

Regulatory Affairs Associate

Functieomschrijving

The Regulatory Affairs Associate has the operational responsibility for registration of dossiers and maintenance of registrations related to the companies entities in Belgium.
He/she has a key role to insure products could be marketed in accordance with regulatory requirements and guidelines.
- Responsible for the optimal preparation, submission and follow-up of registrations (NP, MRP, DCP)
- Interaction and close collaboration with other departments of the local (QA/PV/Medical Affairs) and European Central RA Organization to collect information necessary for submissions
- Administrative support for pricing and reimbursement procedures, in line with the pricing and reimbursement strategy defined by the company
- Actively participate in the management of regulatory projects and implement these.
- Create RA procedures and work according to those procedures/guidelines within the department.
- Assure a good collaboration between the RA department and QA and PV department in order to assure the compliance of marketed products with the current approved registration file.  Ensure compliance with all regulatory requirements.  
 

Profiel

- Bachelor or Master Degree in Health Sciences or proven experience in the pharmaceutical industry 

- 2 to 5 years of relevant experience in Regulatory Affairs with knowledge of national and international regulatory requirements and guidelines on pharmaceutical products

- Good trilingual (write, read, speak): Dutch, French and English

- Excellent organization and project management skills

- Sense of responsibility and accuracy

Vilvoorde - Zaventem

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Kenmerken

  • Functietype: Klinisch onderzoek
  • Sector: Chemie en Pharmacie
  • Hoeilaart (standplaats)
  • Meer over het bedrijf

Vereisten

  • Master (Licentiaat; Universiteit of Hoger Onderwijs Lange Type)
  • Minstens 2 jaar ervaring
  • Nederlands, Frans, Engels

Aanbod

  • Onbepaalde duur
  • Voltijds

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