Senior Manager Regulatory Affairs

Proclinical is working with a leading global consultancy who are currently hiring for a Senior Regulatory Affairs Manager position based in Spain.

Responsibilities

• In this Senior Regulatory Affairs Manager job, you will be responsible for:
• Planning and implementation of approval procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as of life cycle management procedures (variations, renewals, MAH transfer etc.) worldwide
• Communication in the project team, with customers, local partners and authorities in an international context
• Revision of approval documents and text management (labeling management)

Skills and requirements

• You have successfully completed a degree in pharmacy, medicine or other life sciences
• You have at least 3 years of professional experience in marketing authorization with a focus on the EU or non-EU marketing authorization procedures and ideally have experience in launch management, labeling management and clinical trial applications as well as marketing authorization procedures in non-EU countries
• You have sound knowledge of current pharmaceutical and regulatory requirements (EU)
• You have experience in project management, you are multi-tasking capable, enjoy consulting customers and have an affinity for databases and project management software
• You are a team player, communicative, conscientious, accurate and responsible
• Flexibility and willingness to travel
• Confident MS Excel and Word knowledge as well as business fluent English skills complete your profile

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Tanja Ruschenschmidt on or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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