Opening For Regulatory Affairs Specialist - Madrid, Spain

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Amar Annamalai
Amar Annamalai's picture
Opening For Regulatory Affairs Specialist - Madrid, Spain

 Regulatory Affairs Specialist (Biotechnology) – International Pharma / Madrid, Spain
 
On behalf of our Client who are an International Pharma Group currently going through a period of unprecedented expansion, I am looking for an experienced Regulatory Affairs Specialist to join their team in Madrid, Spain developing biosimilar mAbs. In this role you will report to Head of Regulatory Affairs.
 
Responsibilities:
 
Analyzing global submission requirements and submitting regulatory dossiers
Preparation of submission files of new products with respect to local regulations
Monitoring, preparing and following-up on renewals for all registered products
Participation in various internal and external regulatory meetings as required
Maintenance of all files and documentation pertaining to regulatory activities
Dealing with queries from regulatory bodies and health agencies
Desired Skills and Experience:
 
Min. 5 years of experience as a specialist in regulatory affairs with biologics or pharmaceuticals
Preferred experience of working with modules 3, 4 and 5
Good knowledge of regulatory procedures in Europe
Education background in life sciences
Fluency in English, Spanish would be an extra asset
Excellent communication skills
In return you can expect an attractive remuneration and interesting international work environment. If you meet the above criteria and are interested, please send your up-to-date CV with contact details to candidates@pharmaprofessionals.eu