Regulatory Affairs Manager

看过: 195

更新日: 26-11-2025

位置: Beerse Antwerp

类别: 咨询/客户服务

行业: Pharmaceuticals Management Consulting Mechanical or Industrial Engineering

水平: Mid-Senior level

工作类型: Full-time

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工作内容

For one of our bigger pharmaceutical clients, located in Beerse, we are looking for a Regulatory Compliance Manager who can work fully remote.

As a Regulatory Compliance Manager, you will have the following responsibilities:

Supporting the regional regulatory strategy for products in the oncology pipeline
Participating in global regulatory team meetings
Advising the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
Drafting cover letters for Regulatory Agency communication
Assisting in development of processes related to regulatory submissions
Reviewing protocols and ensuring alignment with regulatory requirements
Reviewing and approving clinical trial supply plans
Providing regulatory support throughout registration process and the life-cycle management

As a Regulatory Complaince Manager you will meet the following requirements:

Master degree in medical or paramedical (pharmacy, biology, veterinary,...)
Relevant experience in regulatory affairs
Knowledge of the regulatory environment, guidelines and practice of EMEA regions
Project management skills
A real organisational and multi-tasking expert
Fluent in English and/or Dutch and French

What we can offer:

Challenging projects based on your interests and skills
Personal follow-up and clear, transparent communication both before and after commencement of employment
Possibility to follow extra training
Inspiring network events and legendary after work drinks
Strong network of industry leading clients
Expertise within IT, Engineering and Life Sciences
A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

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