19 ago
|
Neuraxpharm
|
Barcelona
19 ago
Neuraxpharm
Barcelona
WE ARE HIRING
REGULATORY AFFAIRS SPECIALIST - PORTUGAL
Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.
Being part of this team does not mean you are just working for a company, but for a cause
Neuraxpharm is looking for a Regulatory Affairs Specialist based in Portugal/Spain
(remote/hybrid)
Your mission:
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The main focus of this position is to prepare, manage, and submit the documentation required for registration dossiers to the relevant Health Authorities, while ensuring the ongoing maintenance of the company’s marketing authorizations in accordance with quality standards, company policies, and applicable regulatory guidelines and requirements.
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A key objective is to maintain and optimize marketing authorizations throughout the product lifecycle, including the management of variations, renewals, and other post-approval regulatory activities.
This involves proactively monitoring regulatory requirements and ensuring timely submissions in line with the company’s regulatory compliance objectives. These activities are essential to maintaining compliance with all applicable regulations and internal procedures.
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The purpose of the Regulatory Affairs Specialist position for our Portuguese affiliate is to provide local regulatory expertise and manage regulatory activities for products authorized in Portugal. In addition, the role is responsible for coordinating regulatory activities with Neuraxpharm partners in Brazil. The position also requires close collaboration with the Corporate Regulatory Affairs team and, when necessary, management of regulatory activities for corporate products.
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The role further includes providing administrative and technical support for regulatory activities before and after the authorization of medicinal products. This includes ensuring compliance with quality standards, company policies, and
📌 Regulatory Affairs Specialist (Barcelona)
🏢 Neuraxpharm
📍 Barcelona