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Regulatory Affairs Technician

We are looking for a Regulatory Affairs Technician to join the team of our client an important company of the pharmaceutical industry.

Responsibilities:
.Compile, write, review and publish registration dossiers for new product registrations by applying solid international regulatory knowledge and CMC expertise.

. Collaborate effectively with internal partners and global clients for the maintenance of marketing authorizations of all out-licensing activities.
. Consolidate authorized dossiers and perform regulatory activities to ensure regulatory compliance.
. Coordinate working groups for the effective response to deficiency comments from international regulatory agencies and author response documents with support from working groups.

. Provide regulatory support and insight to internal and external partners.
. Collaborate with service providers and coordinate activities with internal/external partners to meet regulatory objectives.
. Maintain regulatory database on a daily basis.
. Coach other junior regulatory specialists in the department.
. Participate in product development activities and periodic meetings with upper management

Requirements:

• +3 years experience experience in Regulatory Affairs Pharma departments.
• Academic Degree in Life Science
• Advanced IT level - (MS Office)
• Proactive, good communication, accurate, detail orientated.

We offer you:
A highly professional, dynamic, ambitious working environment.
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