regulatory expert emea in beerse

posted
job type
tijdelijk
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job details

posted
location
beerse, antwerpen
job category
Chemie & Pharmacie
job type
tijdelijk
reference number
RSBE473088
phone
014/ 60 71 13
apply now

job description

1.Strategic and tactical input in development, post-approval and Life cycle management 2.Liaison with Regulatory Agencies and Local Operating Companies 3.Input in document and process development 4.Clinical Trial Applications (CTA) 5.Marketing Authorization Application (MAA) 6.Resource Planning and Management

qualification

Education and experience *University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience *Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas) *Experience with EU regulatory procedures (CP, MRP, national) *Experience in working in project teams and/or a matrix organization Skills *Negotiating and conflict handling skills *People management skills *Complex project management skills *Oral & written communication skills *Organization & multi-tasking skills Knowledge *Excellent knowledge of English *Knowledge of the applicable therapeutic area *In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions Temporary job June - August 2018