Our client is a world leading Pharmaceutical company, for their Munich office they're currently looking for a:

Regulatory Affairs Specialist - Munich

This role is integral to our Regulatory Affairs department, specifically catering to the European Market. We seek a meticulous professional to oversee all regulatory affairs and quality assurance endeavors, ensuring adherence to local and international regulatory standards.

Responsibilities:

• Establish and implement a robust quality management system within the European Regulatory Affairs (ERA) domain.
• Identify the necessity for best practices, processes, SOPs, tools, and training sessions, facilitating the development of systemic processes.
• Collaborate with stakeholders and internal teams to ensure regulatory compliance across the product lifecycle.
• Provide comprehensive training and guidance to the team on regulatory and quality-related matters.
• Engage in continuous improvement initiatives to bolster compliance and streamline processes.
• Strategically plan ERA projects and systematically track their progress.
• Offer operational support for regulatory submissions and related tasks as required.

Requirements:

• Demonstrated aptitude for learning and adaptation.
• Proficient in project management, with a proven track record of working efficiently under pressure.
• Possess a positive demeanor and foster a collaborative team spirit.
• Excellent interpersonal and communication skills.
• Bachelor's degree or higher, preferably in pharmaceutics.
• Minimum of 7 years of relevant work experience in regulatory affairs or GxP quality assurance.