Senior Manager Regulatory Affairs

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Irfa******

  • Spain 
  • Last Update: 18.01.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
11 Month +
Place
Madrid, ES
Country
Spain

Category


Regulatory, Quality, and Clinical

Description


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

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