Senior Regulatory Affairs Associate
Welwyn Garden City , Herts
to c £45,000
Established Pharmaceutical Company are recruiting a Senior Regulatory Affairs Associate to join their Team.
Reporting to the Regulatory Affairs Manager the role will be responsible for tasks including :
* Manage / Implement pharmaceutical product dossier validation and registration and variations in various Counties, particularly in emerging and international Markets
* Involvement in all aspects of the registration process and document preparation
* Working and project managing cross functional teams
The successful candidate must have international experience of working within regulatory affairs within a generics company with ex - EU Products. Experience of working on various Pharmaceutical product registrations gained over 3-4 years is desired. In addition CMC ( Pharmaceutical Chemistry Manufacturing and Control ), experience of performing gap analysis of technical documents and reviewing / modifying technical dossiers, preparing and submitting project registration application, a working knowledge of labelling and artwork and a working knowledge of Pharmacovigilance is desired.
Advanced competence of spoken and written English is essential, Spanish or Arabic language skills are desired. A graduate ( or equivalent ) of a life sciences discipline is expected.
To find out more and to apply please send your CV
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