Regulatory Affairs and Safety Manager Job in Alken , Netherlands

infarAMA offers services to the health care industry such as regulatory affairs, quality support and translation for medicinal products, herbal remedies, medical devices, cosmetics and food supplements.

Regulatory Affairs and Safety Manager Job Description

Key responsibilities

• Take the lead in CP/DCP/MRP/NP registration procedures.
• Ensure regulatory maintenance and compliance for assigned products/portfolio of clients, pharmaceutical companies.
• Establish, maintain and develop the expertise domains (regulatory affairs, pharmacovigilance, medical information and quality assurance) to enable products, services, strategies and policies to meet required standards.
• Lead, train and manage the team of RA and Safety Officers in their day-to-day tasks such as: submission of registration files, verify product information, Life cycle management of client portfolios, etc.
• Direct report to Managing Directors.

•  At InfarAMA we provide a dynamic and supportive working environment and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages.

Regulatory Affairs and Safety Manager Job Requirements

Profile description

• Scientific degree (pharmacist or biomedical science or equivalent by experience) official recognitions (QP/PV/RIP) and good CMC knowledge are an asset.
• Detailed knowledge of the rules governing medicinal products in the European Union (regulatory affairs, pharmacovigilance, medical information and quality assurance).
• Proven experience in a comparable function in the pharmaceutical industry.
• Exceptional interpersonal and communication skills, ideally trilingual (Dutch, French and English), knowledge of other languages is an asset.
• Strong knowledge of current software.
• Able to function within a quickly changing working environment with a high stress level and continuous time pressure.

Regulatory Affairs and Safety Manager Application Information

Please apply with your CV and cover letter by the 'apply' button below or via: http://infarama.heeft-nieuwe-jobs.be/s/1929/827/en/regulatory-affairs-and-safety-manager-at-infarama/

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Regulatory Affairs and Safety Manager Summary

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