As a successful Regulatory Affairs (RA), Quality Assurance (QA) & Pharmacovigilance (PV) Specialist, you will have the following responsibilities:
Regulatory Affairs:
* Prepare regulatory documentation & registrations dossier for market authorization of Pharma products (cosmetics, food supplements and homeopathic solutions)
* Submit registration documentation to competent authorities worldwide & monitor progress with local authorities
* Ensure update, variations, renewal and validations of regulatory documentations
* Analyze, understand and share relevant regulatory trends related to Pharma products (cosmetics, food supplements and homeopathic solutions)
Quality assurance:
* Participate in Quality Assurance activities: documentation update, internal & external audits, qualifications and validations, complaints handling and deviations
Pharmacovigilance:
* Insure the implementations of phamacovigilance processes & insure conformity of the go to market products
* Follow-up of adverse events with healthcare professionals
* Engage in continuous professional development within pharmacovigilance
As a successful Regulatory Affairs (RA), Quality Assurance (QA) & Pharmacovigilance (PV) Specialist, you have the following profile:
* A degree in LifeSciences, Biomedical, Pharmacy or related field
* Knowledge of EU Regulations within the healthcare industry & Pharmacovigilance.
* +3 years of experiences in Regulatory Affairs/ Quality Affairs/ Pharmacovigilance
* Excellent communication skills - both oral and written - to liaise with various departments and regulatory bodies.
* A strong eye for detail, ensuring all regulatory documents are accurate and complete.
* Capacity to work independently with the ability to analyze and interpret complex regulatory documentation.
* A strong cooperative mindset to liaise and collaborate with the different departments (Safety, Clinical, Marketing ...).
* Fluent in Dutch, English & French
As a successful Regulatory Affairs (RA), Quality Assurance (QA) & Pharmacovigilance (PV) Specialist, you have:
* A competitive fix salary coupled with interesting benefits package (including a Company car)
* An opportunity to work in a highly respected international firm in the Life Sciences industry.
* A diverse function supported by a management valuating proactively, team spirit and well being.
This is a fantastic opportunity for an individual looking to take the next step in their career within the Life Sciences industry. Don't miss out, apply today!