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Senior Manager, Regulatory Affairs
This vacancy has now expired. Please see similar roles below...
A pharmaceutical consulting business is seeking a Senior Manager. Regulatory Affairs to join their base in Spain. For more infomation on the company and exact location, please apply below!
Role Responsibilities:
- 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)
Role Requirements:
- Degree in pharmacy, medicine or other life sciences
- At least 3 years' experience in marketing authorization with a focus on the EU or non-EU marketing authorization procedures and ideally have experience in launch management (DE), labeling management and clinical trial applications (CTA) as well as marketing authorization procedures in non-EU countries
- Knowledge of current pharmaceutical and regulatory requirements (EU)
- Experience in project management, you are multi-tasking capable, enjoy consulting customers and have an affinity for databases and project management software
- Flexibility and willingness to travel
- MS Excel and Word knowledge as well as business fluent English skills
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 on +44 207 440 0632 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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